Universal reference book for medicines
Product name: MARVELON ® (MARVELON ® )

Active substance: desogestrel, ethinylestradiol

Type: Monophasic oral contraceptive

Manufacturer: NV ORGANON (The Netherlands)

Composition, form of production and packaging
Tablets of
white color, round, biconcave, engraved "TR" above the number "5" on one side of the tablet and the inscription "ORGANON" with a five-pointed star on the other side of the tablet.

1 tab.

ethinylestradiol 30 μg

desogestrel 150 μg

Auxiliary substances: potato starch, povidone, stearic acid, silicon dioxide colloid,? -tocopherol, lactose monohydrate.

21 pcs.
- blisters (1) - aluminum foil sachets (1) - packs of cardboard.
21 pcs.
- blisters (1) - aluminum foil sachets (3) - cardboard packs.
21 pcs.
- blisters (1) - aluminum foil sachets (6) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Combined contraceptive drug containing estrogen and progestogen.
The contraceptive effect of Marvelon, as well as of other combined oral contraceptives (CPC), is based, first of all, on the ability to suppress ovulation and increase the secretion of cervical mucus.
The gestagenic preparation (desogestrel) inhibits the synthesis of LH and FSH by the pituitary gland and, thus, prevents the maturation of the follicle (blocks ovulation).

Ethinyl estradiol - a synthetic analogue of the follicular hormone estradiol, together with the hormone of the yellow body regulates the menstrual cycle.

Along with these central and peripheral mechanisms preventing the maturation of an ovum capable of fertilization, the contraceptive effect is due to an increase in the viscosity of mucus located in the cervix, which makes it relatively impenetrable for spermatozoa.

In addition to contraceptive properties, Marvelon ® has a number of effects that can be taken into account when choosing a method of contraception.Menstrualnopodobnye reactions become more regular, flow less painful and are accompanied by less pronounced bleeding.
The latter circumstance leads to a decrease in the frequency of concomitant iron deficiency anemia. When using CPC, a reduction in the risk of ovarian cancer and endometrium was shown.
PHARMACOKINETICS

Desogestrel, taken orally, quickly and completely absorbed and then converted to etonogestrel.
Its maximum concentration in blood plasma (approximately 2 ng / ml) is achieved after 1.5 hours. Bioavailability is 62-81%.
Etonogestrel binds to blood plasma albumin and to sex hormone binding globulin (SHBG).
Only 2-4% of the total concentration of etonogestrel in plasma is present as a free steroid, 40-70% specifically bind to SHBG. An increase in the level of SHBG caused by ethinyl estradiol affects the distribution between blood proteins, leading to an increase in the SHBG-bound fraction and a decrease in the albumin-bound fraction. The apparent volume of distribution of desogestrel is 1.5 l / kg.
Etonogestrel is completely metabolized by the known pathways of the metabolism of steroid hormones;
the rate of metabolic excretion from the blood plasma is 2 ml / min / kg. No interaction of etonogestrel with concomitant ethinyl estradiol was observed.
The concentration of etonogestrel in the blood plasma is reduced in 2 stages.
The final stage is characterized by a half-life (T 1/2 ) of about 30 hours. Dezogesgrel and its metabolites are excreted in the urine and bile in a ratio of approximately 6: 4.
The pharmacokinetics of etonogestrel is influenced by SHBG, the level of which rises by a factor of 3 under the action of ethinyl estradiol.
With daily intake, the concentration of etonogestrel in the blood plasma increases 2-3 times, reaching a constant level in the second half of the cycle.
Ethinyl estradiol after oral administration is quickly and completely absorbed.
Its maximum concentration in blood plasma (about 80 pg / ml) is achieved within 1-2 hours after administration. Absolute bioavailability (the result of presystemic metabolism) is about 60%.
Ethinyl estradiol was non-specifically bound to plasma albumin almost completely (98.5%), contributing to an increase in the concentration of SHBG.
The apparent volume of distribution of ethinylestradiol is 5 l / kg.
Ethinyl estradiol undergoes presystemic metabolism in both the mucosa of the small intestine and the liver.
Ethinyl estradiol is initially metabolized during aromatic hydroxylation to form a variety of hydroxylated and methylated metabolites that are present in both the free state and as conjugates with glucuronides and sulfates.The rate of metabolic clearance of ethinylestradiol from plasma is about 5 ml / min / kg.
The concentration of etonogestrel in the blood plasma is reduced in 2 stages.
The final stage is characterized by T 1/2 for about 24 hours. The drug remains unchanged, the metabolites of ethinyl estradiol are secreted with urine and bile in a ratio of 4: 6. T 1/2 of metabolites is about a day.
INDICATIONS

- Contraception.

DOSING MODE

Tablets should be taken orally in the order given on the package, every day at approximately the same time, with a small amount of water, if necessary.

Take 1 tablet / day for 21 days.
Receiving tablets from the next package should start 7 days after the end of the previous one. During these 7 days menstrual bleeding occurs. Usually, it begins on day 2-3 after the last pill and may not stop before the next package is taken.
How to start taking Marvelon ®

If hormonal contraceptives are not used within the last month , then the drug should be taken on the first day of the menstrual cycle.
You can start taking the drug 2-5 days after the start of the menstrual 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 tablets in the first cycle.
Transition from combined hormonal contraceptives (PDA, vaginal ring or transdermal patch) : it is advisable to start taking Marvelon ® the day after receiving the last active tablet of the previously used drug (the last tablet containing the active substances), but not later than the day after the end of an ordinary break in taking pills 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 Marvelon ® on the day of removal, but not later than the day the new ring was to be inserted or the next patch application was made.
Transition from preparations containing only progestogen ("minipili", injections, implant) or with progestagen-releasing intrauterine system (IUD).
A woman who takes "mini-drank" can switch to taking Marvelon any day; using an implant or IUD - on the day of their removal; using the drug in the form of injections - on the day that the next injection is to be given, in all cases, additional methods of contraception are recommended for the first 7 days of taking Marvelon ® .
After the abortion, made in the first trimester: a woman can start taking the drug immediately.
No need to use any additional methods of contraception.
After childbirth or abortion, made in the II trimester , it is recommended to start taking the drug no earlier than 21-28 days after childbirth or abortion, made in the II trimester of pregnancy.
At the beginning of taking the drug at a later date, it is recommended that barrier methods of contraception be used during the first 7 days of taking Marvelon ® . In any case, if a woman has had sexual intercourse after giving birth or having an abortion prior to taking Marvelon ® , you should exclude pregnancy before taking the drug or wait until the first menstruation.
In case of missed regular intake of the drug

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 it, and follow-up tablets take at the usual time.
If the next pill is delayed for more than 12 hours , the reliability of contraception can be reduced.
In this case, the following rules should be followed:
1. taking pills should never be interrupted for more than 7 days;

2. For adequate suppression of the hypothalamic-pituitary-ovarian system, it is necessary to take the pill 7 days in a row.

Cyclical administration of the drug implies 3 weeks of use.
Therefore, the following recommendations can be made.
Week 1. A woman should take a missed pill as soon as she remembers it, even if it means taking 2 tablets at a time.
Then you should continue the reception in the usual way. Additionally, the barrier contraceptive method should be used for the next 7 days. If a woman has had sexual intercourse within the previous 7 days, the possibility of pregnancy should be considered. The more pills are missed, and the closer the break in taking the drug at the time of sexual intercourse, the higher the risk of pregnancy.
Week 2. A woman should take a missed pill as soon as she remembers it, even if it means taking two tables.
Simultaneously. Then you should continue the reception in the usual way. Provided that the woman took the pills on time for 7 days preceding the first missed dose, there is no need to use additional (non-hormonal) methods of contraception. Otherwise, or if a woman misses more than 1 tablet, it is recommended to use additional methods of contraception within the next 7 days.
Week 3. The reliability of contraception can be reduced, due to a subsequent break in taking the drug.
This can be avoided by adapting the drug regimen. If you use either of the following two schemes, you do not need to use additional contraceptive measures, provided that the woman took the pills on time for 7 days preceding the first missed dose. Otherwise, it is recommended to use one of the two following schemes and also use additional contraceptive measures during the next 7 days.
1. A woman should take the missed pill as soon as she remembers it, even if it means taking 2 tablets at a time.
Then you should continue the reception in the usual way. New packaging should be started as soon as the current packaging is finished, i.e. do not take a break between the packages. The probability of bleeding cancellation before the end of the second package is small, but some may have smearing or copious bleeding even while taking the drug.
2. You can recommend stopping the drug from the current package.
A woman should take a break from taking the Marvelon ® drug for no longer than 7 days, including the days when she forgot to take the pills, and then start a new package.
If you miss a drug and the subsequent absence of bleeding cancellation at the nearest pause in taking pills, you should consider the possibility of pregnancy.

Recommendations in case of occurrence of gastrointestinal disorders

In 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 use the recommendations for missing 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 when you visit an obstetrician-gynecologist.
How to change the period of menstruation

In order to delay menstruation, you should continue taking the tablets from another package of Marvelon ® without the usual interruption in admission.
Delay menstruation can be for any period until the end of table. from the second package. During this period, a woman may have smearing or copious spotting. Admission of the drug according to the usual schedule should be resumed after a 7-day interval in admission.
In order to shift menstruation on a day of the week, which is different from what is expected if the usual intake scheme is followed, you can reduce the usual break in admission for as many days as necessary.
The shorter the break, the higher the risk of a lack of menstruation during the break and the occurrence of copious or spotting spotting while taking the drug from the second package.
SIDE EFFECT

From the cardiovascular system: thrombosis or thromboembolism (including myocardial infarction, stroke, deep vein thrombosis, pulmonary embolism) thromboembolism of the hepatic, mesenteric, renal arteries and veins, arteries of the retina);
increased blood pressure.
From the digestive system: Crohn's disease and ulcerative colitis;
occurrence or exacerbation of jaundice and / or itching associated with cholestasis, cholelithiasis.
On the part of the skin: chloasma (especially if there is a history of chloasma in pregnancy).

From the side of the reproductive system: acyclic spotting more often in the first months of admission.

Other: porphyria, systemic lupus erythematosus, hemolytic-uremic syndrome, minor chorea, herpes of pregnant women, hearing loss due to otosclerosis;
allergic reactions.
Side effects, which were noted with the drug Marvelon ® , but whose relationship with the drug was not proven

Frequently / Infrequently (> 1/1000) Rarely (<1/1000)

From the immune system

hypersensitivity

From the side of metabolism and nutrition

increase in body weight, fluid retention, weight loss

From the nervous system

headache migraine decreased libido depression mood change increased libido

From the side of the organ of vision

intolerance to contact lenses

From the digestive system

nausea, vomiting, abdominal pain, diarrhea

From the skin and subcutaneous tissues

skin rash, urticaria nodosum erythema multiforme erythema

From the side of the reproductive system

pain in the chest soreness of the mammary glands enlargement of the mammary glands secreting from the vagina discharge from the mammary glands



CONTRAINDICATIONS

- Venous or arterial thrombosis / thromboembolism at present or in the anamnesis (including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke);

- harbingers of thrombosis (including transient attacks of IHD, angina pectoris);

- a migraine with focal neurologic symptoms in the anamnesis;

- diabetes mellitus with vascular lesions;

- presence of severe or multiple risk factors for venous or arterial thrombosis (including arterial hypertension with blood pressure 160/100 mm Hg or higher);

- pancreatitis (including in the anamnesis), accompanied by severe hypertriglyceridemia;

- severe liver disease (before the normalization of liver function) (including in the history);

- Liver tumors (benign and malignant) (including in the anamnesis);

- hormone-dependent malignant neoplasms of genital organs or mammary glands (including suspected);

vaginal bleeding of unclear etiology;

- Pregnancy (including presumed);

- the period of lactation (breastfeeding);

- smoking at the age of over 35 years (more than 15 cigarettes a day);

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

- Hypersensitivity to the components of the drug.

If Marvelon ® (like other CPCs) causes any of the above diseases (conditions), stop taking the drug immediately.

Carefully

If any of the conditions / risk factors indicated below are currently available, the potential risk and expected benefits of Marvelon ® should be carefully weighed in each individual case:

- age over 35 years;

- Smoking;

- presence of thromboembolic diseases in a family history (venous or arterial thrombosis / thromboembolism in brothers, sisters or parents at a relatively early age);

- obesity (body mass index> 30 kg / m 2 );

- dyslipoproteinemia;

- arterial hypertension;

- Migraine;

Valvular heart disease;

- atrial fibrillation;

- prolonged immobilization, extensive surgical intervention, surgical intervention on the lower extremities, severe trauma (with prolonged immobilization and the above surgical interventions is recommended

discontinue use of the drug, with planned surgical interventions no later than 4 weeks before surgery, and do not resume admission within 2 weeks after complete remobilization);

varicose veins, superficial thrombophlebitis;

- the postpartum period;

- changes in biochemical parameters that may be markers of a congenital or acquired predisposition to venous or arterial thrombosis (including resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency,

antiphospholipid antibodies, incl.
antibodies to cardiolipin, lupus anticoagulant);
- diabetes;

- systemic lupus erythematosus;

- hemolytic-uremic syndrome;

- chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis);

sickle cell anemia;

- hypertriglyceridemia (including in family history);

- Acute and chronic liver diseases, incl.
congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome).
PREGNANCY AND LACTATION

Use of the drug Marvelon ® pregnancy contraindicated. In case of pregnancy during treatment with Marvelon should stop taking the drug.
Marvelon ® can affect lactation, as CCP reduce the amount and change the composition of breast milk. Therefore Marvelon ® is not recommended until the nursing mother until completely stop breastfeeding. Small amounts of contraceptive steroids and / or their metabolic products may be isolated from breast milk.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindications: presence currently or a history of severe liver diseases (liver function if data are not returned to normal), liver tumors (benign or malignant) (including history).
Precautions: acute and chronic liver disease, including congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor).
SPECIAL INSTRUCTIONS

If any of the following conditions or risk factors should carefully weigh the potential benefits and risks of the drug receiving Marvelon ® . This issue should be discussed with the patient before starting the drug. In the case of aggravation of diseases, deterioration or onset of symptoms of these conditions or risk factors the patient should consult a doctor immediately. The abolition of the drug the doctor decides individually.
Vascular disease
in epidemiological studies have found that there might be a relationship between application of the drug Marvelon ®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 very rare.
Using any CPC associated with an increased risk of venous thromboembolism (VTE) manifesting as deep vein thrombosis and / or pulmonary embolism, sometimes with fatal consequences. The risk is higher in the first year of treatment than in women taking the CCP more than 1 year.
Some epidemiological studies have shown that women who took low-dose PDAs containing progestogens III generation, including desogestrel, have an increased risk of VTE compared with women who took low-dose PDAs containing the progestogen levonorgestrel.
Very rarely thrombosis occurs in other blood vessels (e.g., arteries and veins in the liver, mesentery, kidney, brain or retina). There is no single point of view, whether this is a consequence of the application of the CPC thrombosis.
Increasing the frequency and intensity of migraine headaches when taking the drug Marvelon ® (which may be indicative of cerebrovascular disorders) can serve as a basis for an immediate withdrawal of the drug.
Tumors
The most important factor for cervical cancer risk is the persistence of human papillomavirus (HPV) infection. Some epidemiological studies have noted an increase in the risk of cervical cancer in women receiving long-term Marvelon ®However to date there is controversy regarding the degree of influence of these data the mixing of various factors, such as the screening of cervical screening and sexual behavior, including the use of barrier methods of contraception.
There is evidence that there is a slight increase in the relative risk (1.24) of developing breast cancer in women who use PDAs. The increased risk gradually decreases within 10 years after discontinuation of COCs.
Because in women under 40 years of breast cancer is rare, increase the likelihood of developing breast cancer in women receiving CCP currently or recently refused to use them, is small relative to the initial probability of developing cancer. These studies do not present data on the etiology of cancer. Increased risk of breast cancer can be explained as the fact that women receiving PDA, a breast cancer diagnosis is established at an earlier date, and biological effects of the PDA, or a combination of both these factors.
There is a tendency, according to which women ever took PDAs, breast cancer is clinically less running than in women, never taking the CPC.
Very rarely using Marvelon preparation ®observed cases of benign and even more rarely - malignant liver tumors. In some cases, these tumors have led to life-threatening intra-abdominal bleeding. The physician should take into account the possibility of liver tumor in the differential diagnosis of diseases in a woman receiving Marvelon ® , if symptoms include severe pain in the upper abdomen, the liver increases or signs of intraabdominal bleeding.
Other diseases
If a woman or her family members diagnosed with hypertriglyceridemia, it may increase the risk of pancreatitis when taking the drug Marvelon ® .
If a woman receiving Marvelon ®Develops clinically zachimaya resistant hypertension, the doctor should be abolished Marvelon ® and treat hypertension. In those cases, when using antihypertensive therapy fails to achieve normal blood pressure values, the physician may consider it possible for the resumption of the patient taking the drug.
There are reports that jaundice and / or itching caused by cholestasis; the formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (chorea), herpes gestationis, hearing loss due to otosclerosis (hereditary) angioedema develop or worsen
both during pregnancy and while taking Marvelon drug ®But the evidence against the drug Marvelon ® , are inconclusive.
Acute or chronic disorders of the liver may serve as a basis for cancellation Marvelon preparation ® up until liver function tests are not normalized. Recurrence of cholestatic jaundice observed earlier in pregnancy or use of sex steroids drugs requires the removal of the drug Marvelon ® .
Although Marvelon ® may influence tolerance of the peripheral tissues to insulin and glucose, there is no evidence that patients with diabetes should alter the therapeutic dosage regimen of low-dose PDAs
(containing less than 50 mcg ethinyl estradiol). In any case, during the administration of the drug Marvelon ® diabetics require careful medical supervision.
There is evidence of an association between drug intake Marvelon ® and Crohn's disease and ulcerative colitis.
Sometimes, while taking the drug Marvelon ® may experience pigmentation of the skin (chloasma), especially if it was earlier in the pregnancy. Women with a tendency to chloasma should avoid direct sunlight and UV-radiation from other sources when taking the drug Marvelon ® .
Physicals / consultation
or before resuming reception Marvelon preparation ®the physician should collect detailed medical history and conduct a thorough examination, taking into account the contraindications and warnings. This procedure should be repeated periodically during reception Marvelon preparation ® . Periodic medical examinations are important because of the disease, is a contraindication to receiving the drug Marvelon ® (eg, transient ischemic heart attacks) or risk factors (eg, presence of venous or arterial thrombosis in family history) may first appear during treatment with the drug Marvelon ®. The frequency of inspections and the list must be based on generally accepted practice and matched individually for each woman (but not less than 1 time in 6 months). In any case, special attention should be given to the measurement of blood pressure, the study of the breast, of the abdomen and pelvic organs, including cervical cytology study.
It is necessary to inform the woman that oral contraceptives do not protect against HIV (AIDS) and other sexually transmitted infections through.
Reduced efficacy
The efficacy of the drug Marvelon ® can be reduced in the case of missing ingestion, gastrointestinal disorders or the concomitant taking certain medications.
Irregular bleeding
When receiving the preparation Marvelon® , especially in the first months of use, there may be irregular or heavy smearing spotting. Therefore, irregular bleeding an assessment should be carried out only after the end of the adaptation period of 3 months duration.
If bleeding irregularities persist or occur after previous regular cycles, consider the possible reasons for non-hormonal cycle disorders and to conduct appropriate studies to exclude malignancy or pregnancy. These measures may include a diagnostic curettage.
Some women may be missing menstrualnopodobnoe bleeding during the break between taking the drug. If administration Marvelon ®conducted according to the recommendations above, the probability of pregnancy is low. Otherwise, or if bleeding is not 2 times in a row, to exclude the possibility of pregnancy.
Laboratory studies
Oral contraceptives can affect the results of some laboratory tests, including biochemical liver function tests, thyroid, adrenals and kidneys, the contents of transport proteins in plasma, e.g., corticosteroid-binding globulin, fraction lipid / lipoprotein parameters of carbohydrate metabolism, coagulation parameters and fibrinolysis. Usually, these changes are within the normal range of laboratory parameters.
Lactose
The daily amount of lactose (<80 mg) received in the female organism while taking the drug is such that in women with lactose intolerance unlikely occurrence of complications.
Impact on the ability to drive vehicles and manage mechanisms

Effect of drug Marvelon ® on the ability to drive and operating mechanisms are not observed.
OVERDOSE

Symptoms: nausea, vomiting, and in young girls - bleeding from the vagina. No major complications of drug overdose Marvelon ® was observed.
Treatment: symptomatic therapy.
Antidotes exist.
DRUG INTERACTION

The interaction between oral contraceptives and other drugs can lead to bleeding acyclic and / or reducing contraceptive efficacy. In the literature, the following reaction.
Hepatic metabolism: interaction can occur with inducers of microsomal liver enzymes, which can lead to 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).
Effect pas enterohepatic circulation: According toCynic some data enterohepatic circulation of estrogen can be reduced while the use of certain antibiotics which are capable of reducing kontsentratsiiyu ethinylestradiol in plasma (e.g., penicillins, tetracyclines).
The combined use of atorvastatin and some oral contraceptives containing ethinyl estradiol, ethinyl estradiol AUC increases by about 20%.
Ascorbic acid can increase the concentration of ethinyl estradiol in the plasma, which is possible due to the inhibition of conjugation.
Marvelon ® reduces the effectiveness of indirect anticoagulants, anxiolytics (diazepam), the tricyclic antidepressants, theophylline, caffeine, hypoglycemic drugs, clofibrate and glucocorticoids.
Women who take any of the aforementioned preparations should further temporarily use barrier contraception method or select another method of contraception. With simultaneous use of inducers of microsomal enzymes barrier method of contraception should be used throughout the course of treatment and for 28 days after cessation of treatment. During the reception of antibiotics (except rifampicin and griseofulvin) should be used a barrier method during the entire course of treatment and within 7 days after the end of therapy. If the period during which the barrier method is used, and continues after the end of the tablets in the package PDA, the following product package should start without the usual slot in the reception.
The oral contraceptives may affect the metabolism of other drugs and accordingly modify their concentration in plasma and in tissues (e.g., cyclosporine, salicylic acid, morphine).
By concomitant use of other drugs to determine the possible interactions necessary to use the instruction for the medical use of these medicines.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be kept out of the reach of children, dry, dark place at a temperature of from 2 ° to 30 ° C.
Shelf life - 3 years.
Alphabetical index of medicines:
A  B  V  G  D  E  J
Z  I  Y  K  L  M  N
O  P  R  S  T  U  F
H  C  CH  SH  E  U  Y
Rambler's Top100
Privacy policy:
Copyright 2009 - 2017. Universal reference book of medicines. All rights reserved.
When using site materials, an active hyperlink is required!