New Choice Advanced Formula Nam Ha daily birth control pills (1 blister x 21 tablets)

Dosage form Box of 1 blister x 21 tablets
Specifications Ethinylestradiol, Gestodene

Ingredient

Composition information	Content
Ethinylestradiol	30mcg
Gestodene	75mcg

Uses

indicated

used for contraception.

Pharmacology

NewChoice AD is a combined oral contraceptive, the main effect is the effect of reducing the concentration of FSH and LH, thus not achieving the appropriate concentration and ratio for ovulation, underdeveloped cysts. The main mechanism of impact is to inhibit ovulation, in addition to other mechanisms including: changing cervical mucus (hindering sperm movement into the uterus) and endometrium (reducing the ability to nest of the zygote) to increase the contraceptive effect.

In addition to contraception, birth control pills also have some other positive characteristics:

Effects on menstruation:

The menstrual cycle becomes more even.

Reduce the function of the ovarian cyst.

Reduce fibroids and cystic fibrosis glands.

absorption:

After drinking, Gestodene is absorbed quickly and almost completely. Peak concentration in plasma is about 2-4 ng/ml, achieved after about 1 hour. Bioions about 99%.

Distribution:

Gestodene is associated with plasma albumin and SHBG. Only 1-2% of the total plasma concentration of this substance is free steroids, 50-75% specific to SHBG. The increase in SHBG due to EthinyleLestradiol sensor affects the amount of gestodene attached to plasma proteins, resulting in an increase in cohesion with SHBG and decreases partially associated with albumin. Distribution volume 0.7-1,4 l/kg.

Metabolism:

gestodene is completely metabolized through the known steroid cycle.

Average metabolic speed is 0.8/min/kg.

Era:

Gestodene's plasma concentration decreased by 2 phases. The final phase is characterized by 12-15 hours of sale. Only these metabolites are eliminated through urine and bile in a ratio of 6: 4. Time to sell metabolic waste about 1 day.

Concentration in stable state:

Gestodene pharmacokinetics are affected by SHBG levels, SHBG levels may increase nearly tripled when used with ethinylelestradiol. After drinking every day, plasma concentration increases 3-4 times and reaches the concentration in a stable state in the second half of the treatment cycle.

ethinylestradiol:

absorption:

After drinking, ethinylestradiol is absorbed quickly and completely. The peak concentration of plasma is about 80 PG/ml, achieved within 1-2 hours. Due to the first system conjugate and metabolic effect, the absolute use of EthinyleL milliol has about 60%.

Distribution:

Ethinylelestradiol is strong but not specific to plasma albumin (about 98.5%) and sharply increases SHBG levels in plasma. The integral distribution is from 5 l/kg.

Metabolism:

Ethinylestradiol is metabolized mainly by aromatic hydroxylation hydroxylation. Many metabolites of hydroxylation and methylation are created in the form of free metabolites or glucuronid and sulphat. Metabolic clearance speed is about 5-13 ml/min/kg.

Era:

The plasma concentration of EthinyleLestradiol decreased by 2 phases, the final distribution phase is characterized by the sale time of about 16-24 hours. Only metabolites are eliminated through urine and bile in ratio of 2: 3. Selling time of metabolites is about 1 day.

Concentration in stable state:

The concentration in a stable state is achieved after 3-4 days, when the plasma concentration of this drug is about 20% higher than the concentration after the single dose.

Before taking New Choice Advanced Formula Nam Ha daily birth control pills (1 blister x 21 tablets)

How to use

Do not use Newchoice Ad when suspected of being pregnant or pregnant.

For people who do not use the previous hormonal contraceptives (within the last one month):

Start taking medicine on the first day of the menstrual cycle. You can take NewChoice AD on Monday to Thursday of the menstrual cycle but need to use other contraception in the first 7 days of medication.

Switch from other combined hormonal contraceptives to use Newchoice AD:

It is best to start taking Newchoice AD right after the last day of oral contraceptives of the combined contraceptive pills, but not later than the next day of taking the medication after the week's vacation, or right after the last place of gymnastics of the combined contraceptive pills.

transferred from contraception only containing hormones Progesterone (oral form, injection or subculture form) to newchoice ad:

Transfer of oral contraceptives that contains only progesterone hormones: It is possible to start taking Newchoice AD at any time. Take Newchoice AD right after the use of the contraceptive only containing the last progesterone hormone. But it is necessary to use other contraceptive methods in the first 7 days after starting to use Newchoice AD.

For people with miscarriage or abortion in the first 3 months of pregnancy: It is possible to take Newchoice AD immediately without using any other contraceptive methods. For breastfeeding women (see the part for pregnant and lactating women). If taking the drug later, it is necessary to use other contraceptive methods until the contraceptive has been taken for 7 consecutive days. However, if intercourse, the possibility of pregnancy before taking Newchoice AD or must wait until the first menstrual cycle. The drug should be used at a fixed time of the day. Take 21 capsules in the blister, stop for 7 days without medication. During stopping the drug may appear bleeding (like menstruation). After 7 days, use the next blister without waiting for all bleeding.

What to do when using overdose?

Management: Symptomatic and supportive treatment.

What to do when forgetting a dose? The remaining tablets drink as usual. Contraceptive effects do not decrease.

If the pill is forgotten to take more than 12 hours compared to the daily medication time, the contraceptive effect is not guaranteed, remember the following two basic principles:

Do not stop taking the drug for more than 7 days.

First week:

The last forgotten pills should be taken as soon as possible, this means taking 2 capsules of the same day. The remaining pills are taken as usual. Also should use other contraception in the next 7 days. If the intercourse takes place for 7 days before forgetting the drug, the likelihood of pregnancy should be considered. More and more drugs are missed and the shorter the distance between the pills, the higher the risk of pregnancy.

Week 2:

The last forgotten pills should be taken as soon as possible, which means taking 2 capsules at the same time. The remaining pills are taken as usual. Provided that users who have taken medication continuously within 7 days before forgetting the drug, there is no need to use additional contraception. However, if this is not the case or has missed many capsules, users should use additional contraceptive measures for the next 7 days.

3rd week:

contraceptive effects may be reduced due to forgetting drugs at the 3rd week. However, by adjusting the dose, contraception can still be guaranteed. Therefore, there is no need to apply additional contraception, as long as the previous 7 days, users have taken adequate medication (without missing any tablets). If not, follow one of the following two ways and have other additional contraception in the next 7 days:

Method 1: The last pill is forgotten should be used as soon as possible, even if this means taking 2 capsules at the same time. The remaining birth control pills are taken as usual. The new blister must be started as soon as the contraceptives of the current blister of the drug are gone, meaning that there is no 7 -day leave. Users may not have menstruation until the end of the 2nd drug but may have sudden bleeding or sudden bleeding on the day of taking the drug. Then, take 7 days off, including the days of forgetting to take the medicine and then continue with the new blister. If the user misses some pills and then has no menstruation compared to the first distance of normal use of no drug, it is advisable to consider the possibility of pregnancy. If vomiting or severe diarrhea occurs within 3-4 hours after taking the medication, it is necessary to take a supplement as soon as possible, this must be done within 12 hours from the hour of taking the daily medication to maintain the ability to prevent pregnancy. If more than 12 hours, it is considered that you have forgotten a pill (taken as directed when forgetting 1 pill). The menstrual period may be delayed as desired but not later until the end of the second blister. During this time, the woman may have bleeding.

To change the date of starting period to another day of the week, users may be advised to shorten the gap without drugs. The shorter the distance, the higher the possibility of menstruation, the bleeding may be higher when using the next blister (like when delaying one phase).

Side Effects

The use of contraceptives can do:

Increased the risk of arterial and vein thrombosis including: myocardial infarction, stroke, transient brain anemia, venous thrombosis and pulmonary embolism. > These unwanted effects are more described in the warning and cautious section when taking the drug.

Agency system

popular

Common

(≥1/100 and

Uncommon

(≥1/1000 and

rare

(≥1/10000 and

extremely rare

(

infection and parasitic infection. > Complete. Porphyria). face. in. circuit. Department. menstruation. Normally.

Cervical cancer.

Liver tumor. Because breast cancer is rare in women under 40 years old, too small quantity to assess can cause breast cancer risk. The reason for the use of combined contraceptive oral tablet is not available. For more information to read the contraindications, warning and caution when taking the drug.

Warnings

Contraindicated

Venous thrombosis (VTE) or many serious risk factors affecting venous thrombosis.

is suffering from VTE (using anticoagulic drugs) or a history of VTE (deep vein thrombosis or pulmonary embolism). Effects of many risks (see warning and caution when taking the drug).

Aortic thrombosis (ATE) or many serious risk factors affecting arterial thrombosis.

Having ATE, a history of VTE (such as: myocardial infarction) or showing signs of advance (such as: angina). Phospholipid (anti -cardilipin antibody, anticoagulant lupus). Severe.

Lipoprotein disorders.

There are a history of hormonal tumors (depending on the concentration of sex hormones such as mammary or endometrial cancer) or vaginal bleeding is not diagnosed.

Pregnancy or suspicion of pregnancy.

Newchoice AD is contraindicated simultaneously with drugs containing: Ombitasvir/ paritaprevir/ ritonavir and dasabuvir (see drug interactions).

Be cautious when using

Causes of care when taking the drug:

If there is any of the following risks (factors), it is necessary to consider the benefits of using Newchoice AD with possible risks before making a decision to take the drug.

*circulatory disorders:

Risk of venous thrombosis (VTE):

those who use combined birth control pills (COC), the risk of venous thrombosis (VTE) increases compared to those who do not use. The risk of venous thrombosis is the highest in the first year to start using COC or when using COC after a period of no drug at least one month.

In women who do not use combined contraceptives and do not get pregnant about 2/10,000 people will progress VTE in about 1 year. However, depending on the potential factors of each person, VTE risk may be higher.

It is estimated that among the 10,000 women using contraceptives in combination with Gestodene, 9 to 12 people will progress VTE within 1 year.

Risk factors for venous thrombosis:

The risk of venous thrombosis in contraceptive users can increase significantly in a woman with risk factors, especially for people with many risk factors (see the following table).

NewChoice AD is contraindicated for women with many risk factors that increase the risk of VTE (see the contraindications). For women with more than one risk factor and this risk can increase the risk of VTE rather than the factors mentioned in the contraindications section - in this case, it is necessary to be carefully considered. If the risk is greater than the benefits, it is not allowed to use newchoice ad.

Risk factors:

Risk factors Discussion

Special to review with other risk factors.

Note: Temporary immobilization including traveling by plane> 4 hours may be a risk factor for VTE, especially in people with other risk factors. In these cases, it is advisable to stop using patches/drugs/rounds (if the surgery is stopped by at least 4 weeks before 4 weeks) and does not continue until two weeks after recovery completely. Another method of contraception should be used. Antaginalism treatment should be considered if Newchoice Ad has not stopped using before. > Cancer, systemic lupus, congenital hemolytic syndrome, chronic inflammatory infection (Crohn or ulcerative colitis) and sickle blood cell disease. Venous mass.

Increased VTE risk in pregnant women, and especially in the first 6 weeks after birth (see the section of pregnant and lactating women).

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

When there are symptoms of VTE, you should immediately notify the doctor and make it clear that you are using combined contraceptives.

Deep venous thrombosis:

Swelling of the legs and/or feet or along the leg veins;

Pain or weak legs when standing or walking;

Symptoms of pulmonary embolism:

Suddenly, it is suddenly difficult to breathe in unknown cause or rapid breathing.

Some of these symptoms (such as shortness of breath, cough) are not specific and may be misunderstood such as common or less serious disease (for example: respiratory infections).

Other signs of cerebral embolism may include: sudden pain, swelling and bluish discoloration of a limb.

If the congestion occurs in the eye can be from painless eyes to loss of vision. Sometimes visual loss may occur almost immediately.

Risk of arterial thrombosis (ATE):

Epidemiological studies have shown the effects of combined contraceptive use increases the risk of arterial thrombosis (myocardial infarction) or a stroke (such as transient anemia, stroke). Arterial thrombosis can be fatal.

Risk factors for arterial thrombosis (ATE):

The risk of arterial thrombosis or stroke in the contraceptive user in combination in women with risk factors (see the following table). Newchoice AD is contraindicated for people with one or more risk factors that increase the risk of ATE (see the contraindications). For women with more than one risk factor and this risk can increase the risk of ATE rather than the factors mentioned in the contraindications section - in this case, it is necessary to be carefully considered. If the risk is greater than the benefits, it is not allowed to use newchoice ad.

Risk factors:

Risk factors

Discussion For women who smoke and> 35 years old should use other contraception.

Special to review with other risk factors.

Family members (siblings, parents) used to have a special vein thrombosis before the age of 50. Signs of premature brain vascular problems) may be the reason for stopping using birth control pills immediately. Aortic thrombosis:

When there are symptoms of ATE, you should immediately notify the doctor and stated that it is using combined contraceptives.

Symptoms of a stroke include:

Sudden or weak facial muscles, arms or legs, especially on one side of the body. awakening or fainting, having or not convulsions.

The above symptoms show that this is an anemia (ray).

Symptoms of myocardial infarction (mi) may include:

Pain, discomfort, pressure, severe, compression feeling in the chest, arm or under the breastbone. all.

tumor:

Some epidemiological studies reported: It may increase the risk of cervical cancer in users of contraceptive combined combined but still controversial because this risk is related to interference factors such as sexual behavior and HPV virus. Use combined birth control pills. This risk will disappear for 10 years after stopping using COC. Because breast cancer is rare in women under 40 years old, the number of cases of breast cancer diagnosis in current COC users and has recently been very low compared to the risk of breast cancer. These studies do not provide evidence to the causal relationship.

*Other conditions:

People with triglycerides or family history: may increase the risk of pancreatitis when using combined birth control pills. If happened, immediately stop taking combined birth control pills. For people with high blood pressure using combined contraceptives that blood pressure increases continuously or does not respond when taking the drug, they must stop taking Newchoice AD. Sydenham, herpes and hearing loss caused by atherosclerosis. The recurrence of jaundice occurs for the first time during pregnancy or when using genital steroids before, it is necessary to stop using combined contraceptives. There is a history of melasma due to pregnancy. If you have a melasma tendency, avoid sunlight and ultraviolet rays when using contraceptives.

Health examination and advice:

Before starting or reusing combined contraceptives, a complete medical history is required (including family history) and must eliminate pregnancy. It is necessary to measure blood pressure and health examination to eliminate problems in the part when this drug should not be used (see the contraindications) and the cautious things when taking this medication. The woman should also be carefully read the user guide and follow the instructions given. Women should be informed that oral contraceptives are not protected against HIV infection (AIDS) and other sexually transmitted diseases.

Warning about excipients:

This product contains lactose. Patients with rare genetic problems are galactose intolerance, lactase lactase deficiency or glucose-galactose corrosion disorders should not be taken.

The effect of the drug on driving and operating machinery

Newchoice ad does not have or have a significant impact on the ability to drive and operate machinery.

Use drugs for women during pregnancy and lactation

Pregnant women:

Do not use newchoice ad for pregnant women.

If using newchoice ad during pregnancy should stop taking the drug immediately.

Data on the use of newchoice ad during pregnancy is quite limited to be able to make a negative conclusion of the contraceptive pills for pregnancy and the health of the fetus.

Animal studies do not indicate the direct or indirect effects on pregnancy, the development of the fetus. Most epidemiological studies show that the use of combined birth control pills during pregnancy does not increase the risk of birth defects as well as not causing teratogenicity when used during the early pregnancy.

The risk of increasing VTE during postpartum phase should be considered when starting to reuse newchoice ad.

breastfeeding women:

Small amount of steroid and/ or metabolic substances have been identified in breast milk and some side effects for children have been reported, including jaundice and breast enlargement.

Breast milk may change and change the component if using contraceptives combined. The use of combined contraceptives is not recommended until completely weaned.

Drug interaction

Interaction between birth control pills and other drug products can reduce the effectiveness of contraception and/ or lead to unexpected bleeding and/ or contraceptive failure.

liver metabolism:

Interactions can occur with liver enzyme stimulants that increase the clearance of contraceptive pills (such as phenytoin, barbiturate, primidone, carbamazepine, rifampicin, bententan) and HIV (such as ritonavir, nevirapine) and possibly Oxcarbazepine, Topiramate, Felbamate, Griseofulin Herbal of St. John's Wort (Hypericum Perforatum). For women who are taking liver enzyme induction drugs for a long time, another contraceptive must be used. Simultaneous use with antibiotics can reduce the effect of the drug due to intervention in the intestinal bacteria.

For other pharmaceutical products:

combined birth control pills can affect the metabolism of some other active substances. Accordingly, plasma and tissue concentrations may increase (such as ciclosporin) or decrease (for example, lamotrigine).

Testing:

The use of contraceptive steroids can affect the results of some laboratory tests, including liver, thyroid biochemical parameters, kidney function, plasma concentrations of protein (eg globulin with corticosteroids and dissociators/ lipoprotein), parameters for carbohydrate metabolism, parameters of blood coagulation and fibrin.

Storage

In a dry place, avoid lighting temperatures not exceeding 30 ° C.

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