Marvelon Bayer is used for contraception (3 blisters x 21 tablets)

Dosage form Box of 3 blisters x 21 tablets
Specifications Desogestrel, ethinyletradiol

Ingredient

Composition information	Content
Desogestrel	0.150mg
Ethinylestradiol	0.03mg

Uses

indicated

contraceptive.

Pharmacokology

subgroup ATC G03AA09.

contraceptive effects of contraceptives combine based on the interaction of many different factors, most importantly, the inhibition of ovulation and changes in cervical secretions. As well as protecting contraceptive, combined contraceptives have some positive properties, besides negative properties (see vigilance, unwanted effects), can be helpful in deciding the method of controlling birth. The menstrual cycle is more even, the menstrual period is less painful and less bleeding. This final point reduces iron deficiency. In addition, with high -dose coc (50mcg ethinylelestradiol), there is evidence of reducing the risk of breast fibers, ovarian cysts, pelvic inflammatory infections, ectopic pregnancy and endometrial and ovarian cancer. For low -dose contraceptives, the above effects still need to be confirmed.

Dynamic pharmacokinetics

Desogestrel

absorption

Desogestrel uses orally absorbed quickly and completely, and is transformed into Etonogestrel. The peak concentration of serum is about 1.5 hours. Birth is 62 - 81%.

Distribution

Etonogestrel is associated with serum albumin and with global hormone globulin (SHBG). Only 2 - 4% of the total serum concentration is present in the form of free steroids, 40-70% specific to SHBG. The increase in SHBG caused by EthinyleLestradiol affecting the distribution on serum proteins, increasing the composition associated with SHBG and reducing the composition associated with albumin. Desogestrel's apparent distribution volume is 1.5L/kg.

Metabolism

Etonogestrel is completely metabolized by known steroid metabolism. The speed of clearance from serum is about 2ml/min/kg. No interaction when used with ethinylestradiol.

Elimination

Etonogestrel concentration in serum decreases into two phases. The last phase has a selling time of about 30 hours. Desogestrel and its metabolites are excreted in urine and in bile in a ratio of about 6: 4.

Conditions of concentration stability

Etonogestrel pharmacokinetics are influenced by SHBG concentrations, which is tripled by ethinylestradiol. After taking daily, the serum concentration increases about two - three times, reaching a stable state of concentration in the second half of the treatment cycle.

ethinylestradiol

absorption

Ethinylestradiol is used quickly and completely absorbed. The peak concentration of serum is reached within 1-2 hours. Absolute bioavailability is about 60%, which is a consequence of the combination before entering the blood and the first metabolism in the liver.

Distribution

Ethinylestradiol is mounted but not specific to serum albumin (about 98.5%) and increases SHBG levels in serum. The apparent distribution volume is determined at about 5L/kg.

Metabolism

Ethinyylestradiol is a substance that is conjugated in the small intestinal mucosa and in the liver before entering the blood. EthinylesTradiol is mainly metabolized by aromatic hydroxyl-fragrant but formed a series of metabolites of hydroxyl-glance and methyl-methyl and these substances are present in the form of free metabolites and associated substances with glucuronide and sulfate. Metabolic clearance speed is about 5ml/min/kg.

Elimination

Ethinylelestradiol levels in serum decrease to two phases, the last phase has a half -time -selling time. The drug is not changed, the metabolites of ethinylelestradiol are excreted in urine and in bile in a ratio of 4: 6. Time to sell metabolic waste is about 1 day.

Conditions of concentration stability

The concentration in a stable state is achieved after 3-4 days when the serum concentration is 30-40% higher than when taking the only dose.

Before taking Marvelon Bayer is used for contraception (3 blisters x 21 tablets)

How to use

Need to take the medicine in the order of instructions on the blister of the drug at the same time at the same time as a little water if needed. Take 1 capsule per day for 21 consecutive days. Each of the next blisters will be taken after 7 days without drugs, usually bleeding (menstruation) during these medical holidays. Usually this bleeding will start on the 2nd - 3rd day after taking the last tablet and may not end the bleeding until the beginning of the next new drug.

Dosage

How to start using Marvelon?

No hormonal contraception has not been used (in the previous month)

Start taking medicine on the first day of a woman's natural cycle (meaning the first day of menstruation). Marvelon can start to drink on Monday - 5, but need to use additional diaphragm measures for the first 7 days of medication.

Transferred from contraceptive methods containing coordinated hormones (Oral contraceptive pills (COC), IUD, or contraceptive stickers)

In the same blister of oral contraceptive pills that the woman is using. In case a woman is using an IUD or a contraceptive patch, it is best to start using Marvelon right after the day of removing the ring or sticker, but not later than the date of the next round of placement.

If a woman uses the previous and regular method of contraception and if the woman is not pregnant, it can be transferred from hormonal contraceptives to Marvelon at any day of the cycle.

The time to take medicine for the previous measure should never exceed the recommended number of days.

Changes from contraception only containing progestogen (tablets, injections, implants) or progestogen -releasing uterus loops [IUS]

Women can change any day when changing from birth control pills (if changed from implant or uterine reservations of progestogen adaptation, applicable from the daily injection, if the injection is from the day, it is necessary to be injected from the day, if the injection is from the day, the removal of the drug is needed from the day, if the injection is from the day, it is applicable from the day of the removal or removable, if it is injected from the day, it is from the day of the injection, if the injection is from the time it is needed from the injection, it is necessary to be injected from the injection. Theo), but it is advisable to use more diaphragm measures for the first 7 days from the beginning of using Marvelon.

After miscarriage in the first 3 months

The woman can use Marvelon immediately without using any other contraceptive methods.

After giving birth or miscarriage in 3 months

with breast -feeding women, please see the pregnancy and breastfeeding.

advise women to start taking medicine on 21 to 28 after giving birth or miscarriage in the middle 3 months. The first 7 -day -to -7 -day diaphragm should be used if you start taking the medication later. However, if intercourse, the possibility of getting pregnant before starting to use oral contraceptive combination or a woman needs to wait for the first period.

Increased risk of venous thrombosis (VTE) during the postpartum period should be considered when starting to reuse Marvelon (see carefully and special warnings).

forget to take medicine

If taken late but not more than 12 hours, the effect of protecting contraceptives does not decrease. The woman should take medicine as soon as she remembered and took the next tablets at the usual time.

If you forget to take the medication too late for more than 12 hours, the contraceptive protection effect may be reduced. The management forgot to take medicine based on the following two basic principles:

never stop taking medicine for more than 7 days.
+ Week 1
Take drug users should take the last removal tablet as soon as they remember, even if they have to take two tablets at once. After that, continue taking medication by the usual hour. In addition, a diaphragm should be used as condoms in the next 7 days. If intercourse within 7 days ago, the possibility of pregnancy should be considered. Forgot to take the more tablets and the closer the regular breakdown time, the higher the risk of pregnancy.
+ Week 2
Take drug users should take the last removal tablet as soon as they remember, even if they have to take two tablets at once. After that, continue taking medication by the usual hour. If the woman took the medicine properly in the first 7 days before the first drug was missed, there was no need to use additional methods of additional contraception. However, if not so or if you forget to take more than 1 tablet, you should use additional methods of additional contraception in 7 days.
+ Week 3
The risk of reducing reliability is very large because it has been close to the temporary break. However, by adjusting the medication schedule, it is still possible to prevent the reduction of contraceptive protection. Therefore, if one of the following two options, there is no need to use additional methods of additional contraception, provided that the woman took the medicine properly in the first 7 days before the first pill. If not so, it is advisable to advise the woman to follow the first plan and use additional methods of additional contraception in the next 7 days.
1. Users should take the last pills to miss when remembering, even if they have to take two tablets at a time. After that, continue taking medication by the usual hour. Start drinking to the next blister as soon as you use all the medications you are taking, ie do not have time to leave the medicine between the two blisters. The woman may not see bleeding until she takes the second blister, but it can be seen that blood oozing or abnormal bleeding on the days of taking the medicine. Next, take a break from taking the medicine for a maximum of 7 days, including the days of forgetting to take the medicine and then continue to take a new blister.
2. Advice in case of digestive abnormalities
3. Modifying or postponing menstruation

Side Effects

Unwanted effects may have been reported in clinical trials or observations with Marvelon users or coordinated hormonal contraceptives (CHC) generally listed in the table below 1:

Agency system

popular (1/100) Unsatisfactory (> 1/1000 and

rare ( Translation

Sex Increasing sexual desire circuits Aortic thrombosis 2. Figure
Reproductive and breast disorders Breast pain, breast tightness Big breasts vaginal discharge, breast secretion Weighs The same or related conditions are not listed, but also should be noted.
2 incidence in the research group studies is ≥ 1/10,000 to
The adverse effects are reported in women who use oral contraceptives that are discussed in the warning and cautious use. Including: venous thrombosis, arterial thrombosis; hypertension; The tumor depends on hormones (such as liver tumors, breast cancer); Melasma.
Notify the doctor the unwanted effects when using the drug.

Warnings

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

Contraindicated

should not use hormonal contraceptives (CHC) when there is a manifestation of any situation listed below. Should stop taking the drug immediately if any condition occurs for the first time while taking the hormonal contraceptive pills.

There is or a history of thrombosis (such as deep vein thrombosis, pulmonary embolism). (APC: Activated Protein C), deficiency of Antithrombin III, deficiency of C protein, Homocystein increases in the blood and anti -phospholipid antibodies (anti -cardilipin antibodies, anticoagulants). Or many risk factors for venous thrombosis or artery are also a contraindication (see special and cautious warning before use). Often. Come on.

Be cautious when using

vigilance

If there is any of the following risk factors/factors, it is necessary to consider the benefits of the use of hormonal contraceptives in combination with possible risks for each woman and discuss with the woman before they decide to start taking the drug. In the case of severe, dramatic or first -occurred any risk factor, a woman should see a doctor. The doctor will decide whether or not to continue using hormonal contraceptives.

During this section, the general terms of combined hormonal contraceptives (CHC) are used when there is data on oral oral contraceptives. The terms of oral contraceptives (COC) is used when only data for oral contraceptives.

circulatory disorders

Epidemiological studies have shown the relationship between the use of hormonal contraceptives in combination with increased risk of thrombosis and artery and veins, such as myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism. These complications rarely occur.

The use of hormonal contraceptives in combination with increased risk of venous blockage (VTE) manifests itself as deep vein obstruction and/or pulmonary embolism. This risk is highest in the first year the woman uses hormonal contraceptives. This risk also increases after the first use of hormonal contraceptives or after reusing hormonal contraceptives in combination with the same type or other type after a 4 -week or longer period of stop use. Oral form contains progestogen levonorgestrel. These studies have shown the risk of increasing about twice, equivalent to 1-2 cases of VTE over 10,000 women using each year. However, data from other studies does not show an increased risk of 2 times. Coordination. The ratio of VTE appears when using hormonal contraceptives is less than the ratio related to pregnancy (ie 5 to 20 cases of 10,000 women). Venous thromboembolism causes death in 1-2% of cases. Put the risk of venous thrombolytic embolism into the prospect: If 10,000 women are not pregnant and do not use hormonal contraceptives to be monitored for one year, from 1-5 of these women will generate venous thrombolytic embolism.

*CHC = Coordinated Eve contraceptive pills

** Data on pregnant women is based on actual pregnancy in reference studies. Based on a 9 -month pregnancy assumption model, this ratio is 7 - 27 out of 10,000 women - year (WY).

It is very rare for people who use hormonal contraceptives in combination with venous thrombotic reports that appear in other blood vessels, such as arteries and liver veins, hanging, kidneys, brain or retina. Sudden severe pain in the chest, with or without pain spread to the left hand; Sudden shortness of breath; cough suddenly onset; Many headaches, unusual and prolonged; Suddenly completely lost or part of vision; Song Thi; Tongue or not speaking; dizzy; fainting or without local convulsions; muscle weakness or sudden loss of sensation on one side or part of the body; movement disorders; 'Acute' abdominal pain. If a genetic substance is suspected, a woman should consult an expert before deciding to use any contraceptive methods containing hormones;

overweight (body index exceeds 30kg/m2); In these cases, COC should stop taking coc (at least 4 weeks before the surgery is prepared) and do not use it again until 2 weeks after Hoan is full of campaigning again; (See the contraindications)

and may also have intravenous inflammation in the surface and varicose veins. There is no consensus about the role of these diseases in the cause of venous thrombosis.

The risk of arterial thrombosis increases when:

age increases; The first half of the migraine;

valve disease; If the inherited substance is suspected, the woman should consult experts before starting to use any contraceptive methods containing hormones. Uremia hyperur syndrome caused by hemolytic, chronic colitis (Crohn's disease or ulcerative colitis) and sickle cell anemia. The circuit includes: Activated C protein resistance (APC), increased homocystein - blood, antithrombin - III deficiency, C protein deficiency, Phospholipid antibodies (cardiplet anti -cardiplants, lupus anticoagulant factors).

tumor

The most important risk factor for cervical cancer is the Human Papilloma virus infection (HPV virus (HPV). Epidemiological studies have shown that long -term use can contribute to this risk but still continue to be controversial in uncertainty about the degree of conclusion of this detection for jamming effects, such as increased cervical screening and sexual differences including contraceptive use, or a combination cause. Breast mail increases slightly (RR = 1.24) on women who are using COCs. The risk of surplus gradually disappears within 10 years after stopping using COC. Because it is rare for breast cancer in women under 40 years old, the number of surplus breast cancer is diagnosed on humans and has just used COC is low compared to the risk of breast cancer in a lifetime. These studies do not provide evidence of the cause. The increased risk of the risk may be due to breast cancer that is diagnosed earlier in women using COCs, due to the biological effects of COCS or due to the coordination of both causes. Human diagnostic breast cancer has tended to be less clinically developed than cancer that has been diagnosed on people who have never taken the drug. In special cases, these tumors lead to bleeding in the abdomen that endanger life, need to consider liver tumor in the diagnosis of distinctive diagnosis when pain in the upper abdomen, the liver is enlarged or shows signs of bleeding in the abdominal cavity that occurs in women who are using COCs.

Other conditions

Women with hyperlly blood triglycerides, or have such a family history, may increase the risk of pancreatitis when using COCS. The relationship has not been proven the relationship between combined contraceptive and clinical hypertension. However, if the actual hypertension is clinically significant while using a combined contraceptive tablet, the doctor should be cautious to stop using combined contraceptives and treat hypertension. When appropriate, re -contraceptive can be used if the normal blood pressure is achieved by anti -hypertension therapy. gallstones; Porphyrin metabolism disorders; Lupus system system; Hemorrhage hyperur syndrome due to hemolytic; dance to Sydenham; Herpes during pregnancy; hearing loss due to fibrous fibrosis; Evala (genetic). The recurrence of jaundice occurs for the first time during pregnancy or when using genital steroids, it is necessary to stop using combined contraceptives. However, diabetics should be carefully monitored while using combined contraceptives. Women who tend to have melasma should avoid exposure to the sun or ultraviolet rays while using a combined contraceptive.

When consulting choosing contraception, you should consider all the above information.

Medical examination/medical consultancy

Before starting or reusing Marvelon, you should ask a medical history (including family history) and be eliminated to get pregnant. Blood pressure should be measured and a physical examination should be met, if there are signs of clinical indicators, according to the instructions in the contraindications (see contraindications) and caution (see caution and special warning when used). Should guide women to read carefully and follow the user guidance before use. The frequency and nature of additional reviews should be based on existing practical guidelines and need adaptation for each woman.

Should notify the woman that contraceptive contraceptives against HIV infection (AIDS) and other sexually transmitted diseases

Effective reduction

combined contraceptive pill can reduce the effectiveness in cases such as forgetting to take the medicine (the section forgot to take the medicine), the gastric - intestinal disorders (the advice in cases of digestive abnormalities) or the combined drug (interactive section).

Reduce cycle control effect

For all types of combined contraceptives, irregular bleeding may occur (hemorrhage or abnormal bleeding), especially in the first months of medication. Therefore, the uneven bleeding assessment only means after a period of taking about three cycles.

If irregular bleeding is persistent or occurs after regular menstrual cycles, it is necessary to consider the causes in addition to the hormone and specify adequate diagnosis measures to eliminate malignant or pregnant diseases. These measures may include uterine scrapers.

Over some women, may not see hemorrhage when taking a break. If the combined contraceptive is taken according to the instructions in the dosage and usage, then the woman is not able to get pregnant. However, if you do not take the instructions before you do not see the hemorrhage due to the first vacation or if you do not see the blood of pregnancy in a row, it is necessary to eliminate the possibility of pregnancy before continuing to use a combined contraceptive tablet.

The effect of the drug on driving and operating machinery

does not observe the effect of the drug on the ability to drive and operate machinery.

Using drugs for women during pregnancy and lactation

Marvelon is not only used during pregnancy. If you get pregnant during the time of using Marvelon, you should stop taking the medication. However, epidemiological studies on a large scale show that there is no increase in the risk of abnormalities in children born from the mother who used COCs before pregnancy, nor did she see the effect of monitoring when accidentally taking birth control pills during the early pregnancy.

Milk creation can be affected by contraceptive tablets because they reduce the number and change the composition of breast milk. Therefore, the contraceptive is usually not recommended until the mother has completely weaned for her children. Small amounts of contraceptive steroids and/or their metabolites can be secreted in milk, but there is no evidence that this adversely affects the baby's health.

Drug interaction

Interactions

Interaction between oral contraceptives and other drugs can cause bleeding and/or decrease in contraceptive effects when taken orally. The following interactions have been reported in literature.

Liver metabolism: Interactive can appear with liver -induced drugs, which can lead to the increase in the clearance of sex hormones (such as Hytans, Barbiturate, Primidone, Carbamazepine, Rifampicin, Rifabutin and possibly Oxcarbazepine, Topiramate, Felbamate, Ritonavir, Griseofulvin and products St. John’s Wort).

generally the maximum touch of the enzyme is not observed for 2-3 weeks but then it may last up to 4 weeks after stopping the drug.

Inefficient contraception is also reported with antibiotics such as ampicillin and tetracycline. There is no explanation of the mechanism of this influence.

Women who use any of the above drugs should temporarily use additional contraceptive methods with additional barriers for coc or choose other contraceptive methods. For drugs that cause liver enzymes, the diaphragm method should be used during the time of use at the same time and the drug mentioned above and use up to 28 days after stopping the drug. In the event of a long treatment with enzyme induction drugs in the liver microsom, you should consider using another contraceptive method. Women who use antibiotics (except for rifampicin and griseofulvin, are antibiotics that act as enzyme induction drugs in the liver microsom) should use a contraception for up to 7 days after stopping antibiotics. If the long -term use of the diaphragm after using the last tablet of the COC blister, you should start using the next COC blister without the time of medication.

Oral contraceptive effects can affect drug metabolism. Accordingly, plasma and tissue concentrations may be increased (such as cyclosporin) or decrease (such as lamotrigine).

Note: should consult the prescription information of the drug used simultaneously to determine the possible interaction.

Subclinical tests

Using contraceptive steroids can affect some subclinical tests, including the biochemical parameters of the liver, thyroid, renal and adrenal function, the concentration of proteins (carriers) in plasma, for example, corticosteroid globulin and lipid/lipoprotein components, carbohydrate conversion parameters and blood coagulation parameters. Common changes within normal testing limits.

Storage

Store less than 30 ° C, avoiding light and moisture.

To be out of reach of children, read the instructions carefully before use.

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