Certificate of conformity (COC) Mersilon, pills 21pcs

Mersilon, pills 21pcs

$138.0

Active ingredient:	Desogestrel, Ethinylestradiol
Dosage form:	Pills
Indications for use:	Contraception

Add to wishlist

Categories: Contraceptive, Medication, Obstetrics, gynecology

Description
Reviews (0)

Composition

Active ingredients:

Desogestrel 0.150 mg;

Ethinyl Estradiol 0.020 mg.

Auxiliary substances:

Potato starch 8.0 mg;

Povidone 2.4 mg;

Stearic acid 0.8 mg;

Colloidal silicon dioxide 0.8 mg;

Alpha-tocopherol 0.08 mg;

Lactose monohydrate up to 80 mg

Pharmacological action

Mercilon-estrogen-progestogenic, contraceptive.

Indications

Prevention of pregnancy;
Menstrual cycle disorders.

Contraindications

Tumors of the uterus and breast.
Uterine bleeding.
Venous and arterial thrombosis.
Severe liver and kidney function disorders.
Severe forms of diabetes mellitus.
Severe forms of arterial hypertension.

Side effects

Thrombosis or thromboembolism (including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism), thromboembolism of the hepatic, mesenteric, renal and retinal arteries.
Increased blood pressure.
Hormone-dependent tumors (liver tumors, breast cancer).
Chloasma (especially if there is a history of chloasma during pregnancy).
Acyclic spotting is more common in the first months of use.
Allergic reactions.

Interaction

Interactions between oral contraceptives and other medications can lead to acyclic bleeding and / or reduced effectiveness of contraceptives. The following interactions are described in the literature.

Hepatic metabolism: interactions may occur with drugs that induce microsomal enzymes, which may lead to increased clearance of sex hormones (for example, phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin; and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John’s wort). The maximum induction of enzymes is not observed in the first 2-3 weeks of Mercilon® use, but may occur at the end of 4 weeks after the usual break in taking the drug.

There have also been reports of impaired contraceptive effect when taking Mercilon® with antibiotics such as ampicillin and tetracyclines. The mechanism of this influence is not clear.

Women who take any of the above-mentioned medications should temporarily use an additional method of barrier contraception or choose a different method of contraception.

If microsomal enzyme inducers are used concomitantly, the barrier method of contraception should be used throughout the entire course of treatment and for 28 days after discontinuation of treatment. In the case of long-term treatment with microsomal enzyme inducers, a different method of contraception should be used.

Women using antibiotics (with the exception of rifampicin and griseofulvin, which have the properties of inducers of microsomal enzymes) should use a barrier method of contraception throughout the course of treatment and for 7 days after the end of therapy. If the period during which the barrier method of contraception is used continues even after the end of tablets in the COC package, then the next package of the drug should be started without the usual interval in reception.

Oral contraceptives can affect the metabolism of other medications.

Accordingly, their concentrations in plasma and tissues can change: increase (for example, cyclosporine) or reduce it (lamotrigine).

When treating other medications, to determine possible interactions, you should read the instructions for medical use of these medications.

How to take, course of use and dosage

Tablets should be taken orally in the order indicated on the package, each day at approximately the same time, with a small amount of water, if necessary. Take 1 tablet daily for 21 days. Taking tablets from the next package should be started 7 days after the end of the previous one. During these 7 days, menstrual-like bleeding occurs. It usually begins 2-3 days after taking the last tablet and may not stop until the next package is taken.

How to start taking Mercilon®– If hormonal contraceptives have not been used in the last monthTaking the pill should start on day 1 of the menstrual cycle (i. e., on the first day of menstrual bleeding). You can start taking the drug on the 2nd-5th day of the cycle, but in this case it is recommended to use an additional (non-hormonal) method of contraception during the first 7 days of taking tablets in the first cycle. – Switching from combined hormonal contraceptives (combined oral contraceptive, vaginal ring or transdermal patch)It is advisable to start taking Mercilon®the day after taking the last active tablet of the previously used drug (the last tablet containing active substances), but not later than the day after the end of the usual break in taking tablets or the day after taking the last tablet that does not contain hormones. If a vaginal ring or transdermal patch is used, it is advisable to start taking Mercilon® on the day of their removal, but not later than the day when the new ring should have been inserted or the next patch application should have been made. If the woman used the previous method of contraception consistently and correctly, and if it is reliably known that the woman is not pregnant, in this case, the woman can switch to taking Mercilon® on any day of the cycle. It should be noted that the usual interval in the use of the previous method of contraception should not exceed its recommended duration.

– The transition from products containing only progestogen (“mini-pill”, injection, implant) or from a progestogen-releasing intrauterine system (IUD)

a Woman taking “mini-pill”, can go to the drug Mercilon®any day; using the implant or IUD the day of their removal; use of the drug in the form of injections in the day when they should be following injection, and in all cases within the first 7 days of taking the drug Mercilon® it is recommended to use additional methods of contraception.

– After an abortion performed in the first trimester

, a woman can start taking the drug immediately. There is no need to use any additional methods of contraception.

– After giving birth or having an abortion in the second trimesterFor nursing mothers, see the section “Use during pregnancy and lactation”.

It is recommended to start taking the drug no earlier than 21-28 days after giving birth or having an abortion in the second trimester of pregnancy. When starting taking the drug at a later date, it is recommended to use barrier methods of contraception during the first 7 days of taking Mercilon®. In any case, if a woman has already had sexual contacts after giving birth or having an abortion before taking Mercilon®, pregnancy should be excluded before taking the drug or wait until the first menstruation.

What should I do if I miss the next drug intake?If the next pill is delayed for less than 12 hours, the reliability of contraception does not decrease. A woman should take a pill as soon as she remembers, and take subsequent pills at the usual time.

If the next pill is delayed for more than 12 hours, the reliability of contraception may be reduced. In this case, you should follow the following two rules: :

1. never stop taking pills for more than 7 days. 2. for adequate suppression of the hypothalamic-pituitary-ovarian system, it is necessary to take tablets for 7 consecutive days. The cyclical nature of taking the drug implies 3 weeks of use. Accordingly, the following recommendations can be made:

Week 1A woman should take the missed pill as soon as she remembers, even if it means taking two pills at the same time. Then you should continue the reception according to the usual scheme. Additionally, you should use barrier contraception for the next 7 days. If a woman has had sexual contact within the previous 7 days, the possibility of pregnancy should be considered. The more pills missed, and the closer the break in taking the drug is to the time of sexual intercourse, the higher the risk of pregnancy.

Week 2A woman should take the missed pill as soon as she remembers, even if it means taking two pills at the same time. Then you should continue the reception according to the usual scheme. Provided that the woman took the pills on time during the 7 days preceding the first missed dose, there is no need to use additional (non-hormonal) methods of contraception. Otherwise, or if the woman missed more than 1 pill, it is recommended to use additional methods of contraception for the next 7 days.

Week 3The reliability of contraception may be reduced due to a subsequent break in taking the drug. This can be avoided by adapting the medication regimen. If you use either of the following two regimens, there is no need to use additional contraceptive measures, provided that the woman took the pills on time during the 7 days preceding the first missed dose. Otherwise, it is recommended to use one of the following two schemes and also use additional contraceptive measures for the next 7 days.1. A woman should take a missed pill as soon as she remembers it, even if it means taking two pills at the same time. Then you should continue the reception according to the usual scheme. A new package should be started as soon as the current package is finished, i. e. there should be no break between packages. The probability of “withdrawal bleeding” before the end of the second package is low, but some may experience smearing or heavy spotting while taking the drug. 2. A woman may be advised to stop taking the drug from the current package. A woman should take a break from taking Mercilon® for no more than 7 days, including days when she forgot to take pills, and then start a new package. If you miss taking the drug and the subsequent absence of “withdrawal bleeding” in the next break in taking pills, you should consider the possibility of pregnancy.

Recommendations in case of gastrointestinal disordersIn the presence of severe gastrointestinal disorders, absorption may be incomplete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after taking the drug, you should follow the recommendations regarding skipping the next dose of the drug. If a woman does not want to change her usual intake schedule, she needs to take an additional tablet(s) from another package (the number of additional tablets is determined by a specialist obstetrician-gynecologist at a face-to-face consultation).

How to change the timing of menstrual-like bleedingIn order to delay menstrual-like bleeding, you should continue taking tablets from another package of Mercilon®without the usual break in reception. You can delay menstrual-like bleeding for any period until the end of tablets from the second package. During this period, a woman may experience smearing or profuse spotting. Taking the drug according to the usual scheme should be resumed after a 7-day interval in reception.

In order to shift the day of the onset of menstrual-like bleeding to another day, you can reduce the usual break in taking pills for as many days as necessary. The shorter the break, the higher the risk of no menstrual-like bleeding during the break and the occurrence of heavy or smearing spotting while taking tablets from the second package.

Overdose

No serious complications were observed with an overdose of Mercilon®.

Symptoms that can occur with an overdose: nausea, vomiting, in young girls-spotting from the vagina.

There are no antidotes and further treatment should be symptomatic.

Special instructions

In the presence of any of the following conditions or risk factors, the benefits and possible harms of taking Mercilon®should be carefully weighed. This issue should be discussed with the patient before taking the drug. If the patient’s condition worsens, worsens, or the first symptoms of the above-mentioned conditions or risk factors appear, the patient should immediately consult a doctor. The doctor should decide whether to discontinue the medication.

Vascular diseases

Epidemiological studies have shown that there may be a link between the use of COCs and an increased risk of arterial and venous thrombotic and thromboembolic diseases, such as myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism. These diseases are extremely rare.

The use of any COC is associated with an increased risk of venous thromboembolism (VTE), which manifests itself as deep vein thrombosis and/or pulmonary embolism. The risk is higher in the first year of use than in women taking COCs for more than 1 year.

Some epidemiological studies show that women who took low-dose COCs containing the third generation of progestogens, including desogestrel, have an increased risk of VTE compared to those women who took low-dose COCs containing the levonorgestrel progestogen.

Very rarely, thrombosis occurs in other blood vessels (for example, in the veins and arteries of the liver, mesentery, kidneys, brain, or retina). There is no consensus on whether this thrombosis is due to the use of COCs.

An increase in the frequency and intensity of migraines when taking Mercilon® (which may be a sign of cerebrovascular disorders) may serve as a reason for immediate discontinuation of the drug. Tumors

The most important risk factor for cervical cancer is the persistence of the human papillomavirus (HPV) infection. Epidemiological studies have shown an increased risk of cervical cancer in women who use COCs for a long time, however, to date, there is uncertainty about the extent to which these data are influenced by a mixture of various factors, such as increased cervical screening and differences in sexual behavior, including the use of barrier methods of contraception, or their relationship.

There is evidence that there is a slight increase in the relative risk (1.24) of developing breast cancer in women using COCs. The increased risk gradually decreases over 10 years after COC is discontinued. Since breast cancer is quite rare in women under 40, the increase in the probability of developing breast cancer in women who currently use COCs or have recently stopped using them is small relative to the initial probability of developing cancer. These studies do not provide data on the etiology of cancer. The increased risk of breast cancer can be explained both by the fact that women taking COCs are diagnosed with breast cancer earlier, and by the biological effects of COCs, or a combination of both of these factors. There is a trend that women who have ever taken COCs have less clinically advanced breast cancer than women who have never taken COCs.

Extremely rare cases of benign and even more rare cases of malignant liver tumors have been observed with the use of Mercilon®. In some cases, these tumors have resulted in life-threatening intra-abdominal bleeding. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking Mercilon®, if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other diseases

If a woman or family member is diagnosed with hypertriglyceridemia, there may be an increased risk of pancreatitis when taking Mercilon®.

If a woman using Mercilon® develops persistent clinically significant hypertension, the doctor should discontinue Mercilon®and prescribe treatment for hypertension. In cases where antihypertensive therapy can achieve normal blood pressure values, the doctor may consider it possible for the patient to resume taking the drug.

Jaundice and/or pruritus caused by cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham’s chorea (chorea minor), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema have been reported to develop or worsen both during pregnancy and while taking Mercilon®, but evidence for this regarding the use of Mercilon® is limited. unconvincing.

Acute or chronic hepatic impairment may lead to discontinuation of Mercilon®until liver function indicators return to normal. Relapse of cholestatic jaundice, previously observed during pregnancy or when using sex steroids, requires discontinuation of Mercilon®.

Although Mercilon may affect peripheral tissue tolerance to insulin and glucose, there is no evidence that patients with diabetes mellitus should change the therapeutic regimen of low-dose COCs (containing less than 0.05 mg of ethinyl estradiol). In any case, women with diabetes should be carefully monitored by a doctor while taking Mercilon®.

There is evidence that there is a link between taking COCs and Crohn’s disease and ulcerative colitis.

Sometimes, when taking Mercilon®, pigmentation of the facial skin (chloasma) may occur, especially if it was previously present during pregnancy. Women with a predisposition to chloasma should avoid direct sunlight and ultraviolet radiation from other sources when taking Mercilon®.

Medical examinations/consultations

Before starting or resuming the use of Mercilon®in a woman, it is necessary to collect a detailed medical history (including family history) and conduct a thorough examination. It is necessary to measure blood pressure and in case of clinically significant signs, it is necessary to conduct a physical examination, guided by contraindications and warnings. The woman should be instructed to carefully read these instructions for use and follow the recommendations. The frequency and list of examinations should be based on generally accepted practice and selected individually for each woman (but not less than once every 6 months). The woman should be informed that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.

Reduced efficiency

The effectiveness of Mercilon®may be reduced in the event of missed medication, gastrointestinal disorders, or concomitant use of certain medications (see the section “Interaction with other medications”).

Irregular spotting

When taking Mercilon®, especially in the first months of use, irregular smearing or profuse spotting may occur. Therefore, the assessment of irregular bleeding should be carried out only after the end of the adaptation period, lasting three months.

If irregular bleeding persists or occurs after previous regular cycles, possible non-hormonal causes of the cycle disorder should be taken into account and appropriate studies should be conducted to exclude malignancies or pregnancy. These measures may include diagnostic curettage.

Some women may not experience menstrual-like bleeding in the interval between taking the drug. If Mercilon® was taken according to the recommendations given above, the probability that the woman is pregnant is low. Otherwise, or if there is no bleeding twice in a row, you should exclude the possibility of pregnancy and consult a doctor.

Laboratory tests

Oral contraceptives can affect the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and kidney function, plasma transport protein content, for example, corticosteroid-binding globulin and lipid/lipoprotein fractions, parameters of carbohydrate metabolism, parameters of coagulation and fibrinolysis. Usually, these changes are within the normal values of laboratory parameters.

Lactose

Each Mercilon tablet contains less than 80 mg of lactose. Women with rare hereditary problems, such as lactose intolerance, lactase deficiency, glucose-galactose malabsorption, who follow a lactose-free diet should take into account the lactose content of Mercilon®.

Influence on the ability to drive a car and other mechanisms

There was no effect of Mercilon on the ability to drive a car or work with mechanisms.