Mersilon, tablets 21 pcs

Contraception

• Prevention of pregnancy;

• Menstrual disorders.

Active ingredient

Composition

Active ingredients:

Desogestrel 0.150 mg;

Ethinylestradiol 0.020 mg.

Auxiliary substances:

Potato starch 8.0 mg;

Povidone 2.4 mg;

Stearic acid 0.8 mg;

Silica colloidal dioxide 0.8 mg;

Alpha-tocopherol 0.08 mg;

Lactose monohydrate up to 80 mg.

How to take, the dosage

The tablets should be taken orally in the order shown on the package at approximately the same time each day, with a little water if necessary. Take 1 tablet a day for 21 days. The pills from the next package should be started 7 days after the end of the previous one. During these 7 days, menstrual bleeding occurs. It usually begins on the 2nd or 3rd day after taking the last pill and may not stop until the beginning of the next package.

How to start taking Mersilon®
How to start taking Mersilon.- If no hormonal contraceptives have been used in the last month

The pills must be started on the 1st day of your menstrual cycle (i.e.i.e. on the first day of menstrual bleeding). It is possible to start taking the drug on day 2-5 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 the pills in the first cycle.
– Switching from combined hormonal contraceptives (combined oral contraceptive, vaginal ring or transdermal patch)
It is advisable to start Mersilon® the day after taking the last active tablet of the previously used medication (the last tablet containing the active ingredients), but no later than the day after the end of the usual pill break or the day after taking the last hormone-free tablet. If a vaginal ring or transdermal patch is used, it is advisable to start Mersilon® on the day it is removed, but no later than the day the new ring or the next patch application is due.
If the woman has used the previous method of contraception consistently and correctly and if it is known that the woman is not pregnant, in this case the woman may switch to Mersilon® on any day of the cycle.
It should be borne in mind that the usual interval in the use of the previous method of contraception should not exceed its recommended duration.

Transition from gestagen-only drugs (“mini-pills,” injections, implant) or from a gestagen-releasing intrauterine system (IUD)

A woman taking a “minipili” can switch to taking Mersilon® on any day; using an implant or IUD, on the day they are removed; using the drug as an injection, on the day the next injection is due; in all cases, additional contraceptive methods are recommended for the first 7 days of taking Mersilon®.

After an abortion performed in the first trimester

The woman may begin taking the drug immediately. There is no need to use any additional methods of contraception.

After delivery or an abortion performed in the second trimester
For breastfeeding mothers, see “Use in pregnancy and during breastfeeding.”

It is recommended that the drug be started no earlier than 21-28 days after delivery or an abortion performed in the second trimester of pregnancy. If you start taking the drug at a later date, it is recommended to use barrier methods of contraception during the first 7 days of taking Mersilon®. In any case, if a woman has already had sexual intercourse after childbirth or abortion before starting Mersilon®, pregnancy should be ruled out before taking the drug or wait until her first menstrual period.

How to proceed if the next pill is missed
If the next pill is missed by less than 12 hours, the reliability of contraception is not reduced. The woman should take the pill as soon as she remembers it and take the subsequent pills at the usual time.

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

1. The pill should never be interrupted for more than 7 days.
2. For adequate suppression of the hypothalamic-pituitary-ovarian system, the pills must be taken for 7 consecutive days.
The cycle of taking the drug implies 3 weeks of use. Accordingly the following recommendations can be made:

Week 1
The woman should take the missed pill as soon as she remembers it, even if it means taking two pills at once. The woman should then continue taking the usual regimen. Additionally, a barrier contraception method should be used for the next 7 days. If the woman had sexual contacts during the previous 7 days, you should consider the possibility of pregnancy. The more pills are missed, and the closer the break in taking the drug to the time of sexual intercourse, the higher the risk of pregnancy.

Week 2
The woman should take the missed pill as soon as she remembers it, even if it means taking two pills at once. The woman should then continue taking it as usual. Provided the woman has taken the pills on time during the 7 days preceding the first missed dose, there is no need to use additional (non-hormonal) contraceptive methods. Otherwise, or if the woman missed more than 1 pill, additional contraceptive methods are recommended for the next 7 days.

Week 3
Contraceptive reliability may be reduced by subsequent discontinuation of the drug. This can be avoided by adapting the regimen of the drug. If either of the following two regimens is used, no additional contraceptive measures are necessary, provided that the woman has taken the pills on time in the 7 days preceding the first missed dose. Otherwise, it is recommended to use one of the following two regimens and also use additional contraceptive measures for the next 7 days.
1. The woman should take the missed pill as soon as she remembers it, even if it means taking two pills at once. Then she should continue taking it according to the usual regimen. A new pack should be started as soon as the current pack is finished, i.e., you should not take a break between packs. The probability of occurrence of “bleeding cancellation” before the end of the second package is insignificant, but some people may have oozing or abundant bloody discharge while taking the drug.
2. The woman may be advised to stop taking the drug from the current package. The woman should take a break from Mersilon® for no more than 7 days, including the days she forgot to take the pills, and then start a new package.
If one misses taking the drug and then does not have a “bleeding withdrawal” at the next break in taking the pills, the possibility of pregnancy should be considered.

Recommendations in case of gastrointestinal distress
In the presence of severe gastrointestinal distress, absorption may be incomplete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours of taking the drug, the recommendations regarding skipping the next dose of the drug should be used. If the woman does not want to change her usual regimen, she should take additional tablet(s) from another package (the number of additional pills is determined by a specialist obstetrician/gynecologist at a face-to-face consultation).

How to change the timing of menstrual bleeding
. To delay menstrual bleeding, continue taking pills from another package of Mersilon® without taking a regular break. Menstrual bleeding can be delayed for any length of time until the end of the pills from the second package. During this period, a woman may have oozing or profuse bleeding. Reception of the drug according to the usual scheme should be resumed after a 7-day interval in the intake.

In order to shift the start day of menstrual bleeding to another day, it is possible to shorten the usual break in taking the pills by as many days as necessary. The shorter the interval, the greater the risk of no menstrual bleeding during the interval and of heavy or smeared bleeding when you take your second pack of pills.

Interaction

Interactions between oral contraceptives and other medications may result in acyclic bleeding and/or decreased contraceptive effectiveness. The following interactions have been described in the literature.

Hepatic metabolism: Interactions may occur with drugs that induce microsomal enzymes, which may result in increased clearance of sex hormones (e.g., phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin; and possibly also oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin and preparations containing St. John’s Wort). Maximum enzyme induction is not seen in the first 2 to 3 weeks of Mersilon® administration, but may occur at the end of 4 weeks after a normal interruption of the drug.

An impairment of the contraceptive effect has also been reported when Mersilon® is taken with antibiotics such as ampicillin and tetracyclines. The mechanism of this effect is not clear.

Women taking any of the above drugs should temporarily use an additional barrier contraceptive method or choose a different contraceptive method.

If microsomal enzyme inducers are used concomitantly, barrier contraception should be used for the duration of treatment and for 28 days after discontinuation of treatment. In case of long-term treatment with the use of microsomal enzyme inducers, another method of contraception should be used.

Women who use antibiotics (except rifampicin and griseofulvin, which have properties of inducers of microsomal enzymes) should use a barrier method of contraception for the duration of treatment and for 7 days after the end of therapy. If the period during which the barrier method of contraception is used continues after the pills in the OC pack are finished, the next pack of the drug must be started without the usual interval in taking.

The oral contraceptives may affect the metabolism of other medications.

These may change their plasma and tissue concentrations accordingly: increasing (e.g., cyclosporine) or decreasing (lamotrigine).

When treating with other medicines, the instructions for medical use of these medicines should be consulted to determine possible interactions.

Special Instructions

If any of the following conditions or risk factors are present, the benefits and possible harms of taking Mersilon® should be carefully weighed. This should be discussed with the patient before starting the drug. If the disease worsens, deteriorates or if the first symptoms of the above-mentioned conditions or risk factors appear, the patient should immediately consult a doctor. The physician should decide whether the drug should be withdrawn.

vascular disease

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

Some epidemiological studies show that women who have taken low-dose OCs containing the third generation of gestagens, including desogestrel, have an increased risk of VTE compared to those who have taken low-dose OCs containing the gestagen levonorgestrel.

It is extremely rare for thrombosis to occur in other blood vessels (e.g., veins and arteries in the liver, mesentery, kidney, brain, or retina). There is no consensus on whether this thrombosis is due to the use of OCs.

An increase in the frequency and intensity of migraines while taking Mersilon® (which may be a sign of cerebrovascular disorders) may warrant immediate withdrawal. Tumors

The most important risk factor for cervical cancer is persistence of human papillomavirus (HPV infection). Epidemiologic studies have shown an increased risk of cervical cancer in women with long-term use of OCs, but to date there is uncertainty about the extent to which a mix of factors, such as increased cervical screening and differences in sexual behavior, including use of barrier methods of contraception, or their interrelation, influence this data.

There is evidence that there is a small increase in the relative risk (1.24) of developing breast cancer in women who use OCs. The increased risk gradually decreases over a 10-year period after withdrawal of OCs. As breast cancer is relatively rare in women under 40 years of age, the incremental risk for breast cancer in women currently using OC or who have recently stopped using them is small relative to the initial odds of developing cancer. There are no data on the etiology of the cancer in these studies. The increased risk of breast cancer may be explained either by the earlier diagnosis of breast cancer in women taking OC, by the biological effects of OC, or by a combination of both. There is a tendency for women who have ever taken OC to have less clinically advanced breast cancer than women who have never taken OC.

It is extremely rare that cases of benign, and even more rare, malignant liver tumors have been observed with Mersilon®.
In some cases, these tumors have resulted in life-threatening intra-abdominal bleeding. The physician should consider the possibility of a liver tumor in the differential diagnosis of disease in a woman taking Mersilon® if symptoms include acute upper abdominal pain, liver enlargement, or signs of intra-abdominal bleeding.

Other conditions

If a woman or her family members are diagnosed with hypertriglyceridemia, there may be an increased risk of pancreatitis when taking Mersilon®.

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

There have been reports that jaundice and/or pruritus caused by cholestasis; gallstone formation, porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, Sydenham’s chorea (minor chorea), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema develop or worsen both during pregnancy and while taking Mersilon®, but the evidence for this as it relates to taking Mersilon® is inconclusive.

Acute or chronic liver function abnormalities may warrant discontinuation of Mersilon® until liver function parameters return to normal. A recurrence of cholestatic jaundice previously observed during pregnancy or with the use of sex steroid medications requires discontinuation of Mersilon®.

While Mersilon® may affect peripheral tissue insulin and glucose tolerance, there is no evidence that diabetic patients need to change their therapeutic regimen of low-dose OCs (containing less than 0.05 mg ethinylestradiol). In any case, women with diabetes mellitus should be closely monitored by a physician while taking Mersilon®.

There is evidence that there is an association between taking OCs and Crohn’s disease and ulcerative colitis.

Sometimes facial skin pigmentation (chloasma) can occur while taking Mersilon®, 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 Mersilon®.

Medical examinations/consultations

Before starting or renewing use of Mersilon® in a woman, a detailed medical history (including family history) and a thorough examination must be taken. Blood pressure should be measured and if clinically significant, a physical examination should be performed, guided by contraindications and cautions. The woman should be instructed to read these instructions for use carefully and to adhere to the recommendations. The frequency and list of examinations should be based on common practice and chosen individually for each woman (but at least once every 6 months).
The woman should be informed that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections.

Decreased effectiveness

The effectiveness of Mersilon® may decrease if you miss a dose, have gastrointestinal distress, or are taking certain medications concomitantly (see “Interaction with other medicines” Interaction with other medicines The effectiveness of Mersilon may decrease if you miss a dose, have gastrointestinal distress, or if you are taking certain medicines concomitantly. See section “Interaction with other medicinal products”).

Irregular bleeding

When taking Mersilon®, especially during the first few months of use./sup>, especially during the first months of use, irregular, heavy bleeding may occur. Therefore, irregular bleeding should only be evaluated after an adjustment period of three months is complete.

If irregular bleeding persists or occurs after previous regular cycles, possible non-hormonal causes of cycle irregularity should be considered and appropriate tests should be performed to rule out malignancy or pregnancy. These measures may include a diagnostic curettage.

Some women may not have menstrual-like bleeding between doses of the drug. If Mersilon® was taken as recommended above, there is little chance that the woman is pregnant. If not, or if bleeding is absent on two consecutive occasions, the possibility of pregnancy should be ruled out and a doctor consulted.

Lab tests

. Oral contraceptives may affect the results of several laboratory tests, including biochemical indicators of liver, thyroid, adrenal and kidney function, plasma transport proteins such as corticosteroid-binding globulin and lipid/lipoprotein fractions, carbohydrate metabolism parameters, coagulation and fibrinolysis parameters. Usually these changes are within the limits of normal values of laboratory indices.

Lactose

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

Influence on the ability to drive and operate machinery

There is no effect of Mersilon® on the ability to drive and operate machinery.

Contraindications

Side effects

Overdose

No serious complications have been observed with overdose of Mersilon®.

Symptoms that may occur in case of overdose: nausea, vomiting, in young girls – bloody vaginal discharge.

There are no antidotes and further treatment should be symptomatic.

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