Rigevidon instructions for use reviews. "Rigevidon": who is this contraceptive suitable for, and what are the possible side effects

Combined monophasic oral hormonal contraceptive drug. When taken orally, it inhibits the pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As a gestagenic component (progestin), it contains a derivative of 19-nortestosterone - levonorgestrel, which is more active than the corpus luteum hormone progesterone (and a synthetic analogue of the latter - pregnin), acts at the receptor level without preliminary metabolic transformations. The estrogenic component is ethinyl estradiol.

Under the influence of levonorgestrel, the release of LH and FSH from the hypothalamus is blocked, the secretion of gonadotropic hormones by the pituitary gland is inhibited, which leads to inhibition of the maturation and release of an egg ready for fertilization (ovulation). The contraceptive effect is enhanced by ethinyl estradiol. Maintains high viscosity of cervical mucus (makes it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect, when taken regularly, it normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Ethinyl estradiol

Ethinyl estradiol is rapidly and almost completely absorbed from the intestine. Ethinyl estradiol undergoes a “first pass” effect through the liver, T max is 1.5 hours, T 1/2 is about 26 hours.

When taken orally, ethinyl estradiol is cleared from the blood plasma within 12 hours, T1/2 is 5.8 hours.

Ethinyl estradiol is metabolized in the liver and intestines. Ethinyl estradiol metabolites are water-soluble sulfate or glucuronide conjugates that enter the intestine with bile, where they undergo disintegration with the help of intestinal bacteria.

Metabolized in the liver, T1/2 is 2-7 hours.

Ethinyl estradiol is excreted by the kidneys (40%) and through the intestines (60%).

Excreted in breast milk.

Levonorgestrel

After oral administration, levonorgestrel is rapidly absorbed (in less than 4 hours). Levonorgestrel does not undergo a first-pass effect through the liver. When levonorgestrel is co-administered with ethinyl estradiol, there is a relationship between the dose and maximum plasma concentration. T max (time to reach maximum concentration) of levonorgestrel is 2 hours, T 1/2 - 8-30 hours (average 16 hours). Most of levonorgestrel binds in the blood to albumin and SHBG (sex hormone binding globulin). Metabolized in the liver.

Levonorgestrel is excreted by the kidneys (60%) and through the intestines (40%).

Excreted in breast milk.

Release form

White film-coated tablets, round, biconvex.

Excipients: colloidal silicon dioxide - 0.275 mg, magnesium stearate - 0.55 mg, talc - 1.1 mg, corn starch - 19.895 mg, lactose monohydrate - 33 mg.

Shell composition: sucrose - 22.459 mg, talc - 6.826 mg, calcium carbonate - 3.006 mg, titanium dioxide - 1.706 mg, copovidone - 0.592 mg, macrogol 6000 - 0.148 mg, colloidal silicon dioxide - 0.146 mg, povidone - 0.088 mg, carmellose sodium - 0.029 mg.

21 pcs. - blisters (1) - cardboard packs.
21 pcs. - blisters (3) - cardboard packs.

Dosage

The drug is taken orally, without chewing and with a small amount of liquid.

If hormonal contraception was not used during the previous menstrual cycle, then Rigevidon ® for contraception is prescribed from the 1st day of menstruation, 1 tablet daily for 21 days. This is followed by a 7-day break, during which menstrual-like bleeding occurs. The next 21-day cycle of taking tablets from a new package containing 21 tablets must begin the day after the 7-day break, i.e. on the 8th day, even if the bleeding has not stopped. Thus, the start of taking the drug from each new package occurs on the same day of the week.

When switching to taking Rigevidon from another oral contraceptive, a similar scheme is used. The drug is taken as long as the need for contraception continues.

After childbirth, the drug can be prescribed only to women who are not breastfeeding; You should start taking the contraceptive no earlier than the 1st day of menstruation. During lactation, the use of the drug is contraindicated.

The missed pill should be taken within the next 12 hours. If 36 hours have passed since the last pill was taken, then contraception is unreliable. To avoid intermenstrual bleeding, the drug should be continued from the package already started, with the exception of the missed tablet(s). In cases of missed pills, it is recommended to additionally use another, non-hormonal method of contraception (for example, barrier).

For medicinal purposes, the doctor determines the dose of Rigevidon and the regimen of use in each case individually.

Overdose

Cases of toxic effects due to overdose are unknown.

Interaction

Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can enhance the metabolism of the steroid hormones included in the drug.

A decrease in contraceptive effectiveness can also be observed when administered simultaneously with certain antimicrobial agents (including ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with changes in intestinal microflora.

When used simultaneously with anticoagulants, coumarin or indanedione derivatives, additional determination of the prothrombin index and a change in the dose of the anticoagulant may be required.

When using tricyclic antidepressants, maprotiline, beta-blockers, their bioavailability and toxicity may increase.

When using oral hypoglycemic drugs and insulin, it may be necessary to change their dose.

When combined with bromocriptine, its effectiveness decreases.

When combined with drugs with potential hepatotoxic effects, for example, with the drug dantrolene, increased hepatotoxicity is observed, especially in women over 35 years of age.

Side effects

The drug is usually well tolerated.

Possible side effects of a transient nature, spontaneously passing: nausea, vomiting, headache, engorgement of the mammary glands, changes in body weight and libido, mood changes, acyclic bleeding; in some cases - swelling of the eyelids, conjunctivitis, blurred vision, discomfort when wearing contact lenses (these phenomena are temporary and disappear after discontinuation without prescribing any therapy).

With long-term use, chloasma, hearing loss, generalized itching, jaundice, calf muscle cramps, and an increase in the frequency of epileptic seizures can very rarely occur.

Hypertriglyceridemia, hyperglycemia, decreased glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, jaundice, skin rashes, changes in the nature of vaginal secretion, candidiasis, fatigue, diarrhea are rarely observed.

Indications

• oral contraception;
• functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia);
• premenstrual tension syndrome.

Contraindications

• severe liver disease;
• congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome, Rotor syndrome);
• cholecystitis;
• presence or history of severe cardiovascular and cerebrovascular diseases;
• thromboembolism and predisposition to them;
• malignant tumors (primarily breast or endometrial cancer);
• liver tumors;
• familial forms of hyperlipidemia;
• severe forms of arterial hypertension;
• endocrine diseases (including severe forms of diabetes);
• sickle cell anemia;
• chronic hemolytic anemia;
• vaginal bleeding of unknown etiology;
• hydatidiform mole;
• migraine;
• otosclerosis;
• history of idiopathic jaundice in pregnancy;
• severe skin itching during pregnancy;
• herpes during pregnancy;
• age over 40 years;
• pregnancy;
• lactation period (breastfeeding);
• hypersensitivity to the components of the drug.

The drug should be used with caution in diseases of the liver and gallbladder, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, diabetes mellitus, diseases of the cardiovascular system, arterial hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, chorea minor, intermittent porphyria, latent tetany, bronchial asthma, in adolescence (without regular ovulatory cycles).

Features of application

Use during pregnancy and breastfeeding

The drug is contraindicated during pregnancy and lactation (breastfeeding).

Use for liver dysfunction

Contraindicated for use in severe liver diseases (including congenital hyperbilirubinemia - Gilbert, Dubin-Johnson and Rotor syndromes; liver tumors).

Use for renal impairment

Caution is required when prescribing the drug to patients with impaired renal function.

Use in elderly patients

Contraindicated over the age of 40 years.

special instructions

Before starting the use of hormonal contraception and subsequently every 6 months, a general medical and gynecological examination is recommended, including a cytological analysis of a smear from the cervix, assessment of the condition of the mammary glands, determination of blood glucose, cholesterol and other indicators of liver function, blood pressure monitoring, and urine analysis.

Prescribing Rigevidon to women with thromboembolic diseases at a young age and a family history of increased blood clotting is not recommended.

The use of oral contraception is allowed no earlier than 6 months after viral hepatitis, provided that liver function is normalized.

If sharp pain appears in the upper abdomen, hepatomegaly and signs of intra-abdominal bleeding, a suspicion of a liver tumor may arise. If necessary, the drug should be discontinued.

If liver function is impaired while taking Rigevidon, consultation with a physician is necessary.

If acyclic (intermenstrual) bleeding occurs, Rigevidon should be continued, because in most cases, these bleedings stop spontaneously. If acyclic (intermenstrual) bleeding does not disappear or recurs, a medical examination should be performed to exclude organic pathology of the reproductive system.

In case of vomiting or diarrhea, the drug should be continued using another, non-hormonal method of contraception.

Women who smoke and take hormonal contraceptives have an increased risk of developing cardiovascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women over 35 years of age).

The drug should be stopped in the following cases:

• when a migraine-like headache appears for the first time or worsens;
• when an unusually severe headache appears;
• when early signs of phlebitis or phlebothrombosis appear (unusual pain or swelling of the veins in the legs);
• if jaundice or hepatitis without jaundice occurs;
• for cerebrovascular disorders;
• when there is stabbing pain of unknown etiology when breathing or coughing, pain and a feeling of tightness in the chest;
• with acute deterioration of visual acuity;
• if thrombosis or heart attack is suspected;
• with a sharp increase in blood pressure;
• when generalized itching occurs;
• with increased frequency of epileptic seizures;
• 3 months before the planned pregnancy;
• approximately 6 weeks before the planned surgical intervention;
• with prolonged immobilization;
• during pregnancy.

Impact on the ability to drive vehicles and operate machinery

Taking the drug does not affect the ability to drive vehicles or operate other mechanisms, the operation of which is associated with an increased risk of injury.

P N012676/02

Tradename:

RIGEVIDON ®

International nonproprietary name or generic name:

Ethinyl estradiol + Levonorgestrel

Dosage form:

film-coated tablets

COMPOUND

Active substances:
Ethinyl estradiol: 0.03 mg
Levonorgestrel; 0.15 mg
Excipients:
- in the tablet core: colloidal silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate;
- in the tablet shell: sucrose, talc, calcium carbonate, titanium dioxide, copovidone, macrogol 6000, colloidal silicon dioxide, povidone, carmellose sodium.

Description

White, round, biconvex, film-coated tablets.

Pharmacotherapeutic group:

contraceptive (estrogen + gestagen)

ATX Code: G03AA07.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Rigevidon is an oral monophasic combined estrogen-progestogen contraceptive drug.
When taken orally, it inhibits the pituitary secretion of gonadotropic hormones.
The contraceptive effect is associated with several mechanisms. As a gestagenic component (progestin), it contains a derivative of 19-nortestosterone - levonorgestrel, which is more active than the corpus luteum hormone progesterone (and a synthetic analogue of the latter - pregnin), acts at the receptor level without preliminary metabolic transformations. The estrogenic component is ethinyl estradiol. Under the influence of levonorgestrel, there is a blockade of the release of releasing hormones (LH and FSH) of the hypothalamus, inhibition of the pituitary gland's secretion of gonadotropic hormones, which leads to inhibition of the maturation and release of an egg ready for fertilization (ovulation). The contraceptive effect is enhanced by ethinyl estradiol. Maintains high viscosity of cervical mucus (makes it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect, when taken regularly, it normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, incl. tumor nature.

Pharmacokinetics

Levonorgestrel is rapidly absorbed (less than 4 hours). Levonorgestrel does not have a first-pass effect through the liver. When levonorgestrel is co-administered with ethinyl estradiol, there is a relationship between the dose and maximum plasma concentration. TC max (time to reach maximum concentration) of levonorgestrel is 2 hours, T 1/2 (half-life) - 8-30 hours. (on average 16 hours). Most of levonorgestrel binds in the blood to albumin and SHBG (sex hormone binding globulin).
Ethinyl estradiol quickly and almost completely absorbed from the intestines. Ethinyl estradiol has a first-pass effect through the liver, TC max is 1.5 hours, half-life is about 26 hours.
When taken orally, ethinyl estradiol is released from the blood plasma within 12 hours, the half-life is 5.8 hours.
Ethinyl estradiol is metabolized in the liver and intestines. Ethinyl estradiol metabolites are water-soluble products of sulfate or glucuronide conjugation and enter the intestine with bile, where they undergo disintegration with the help of intestinal bacteria.
Both components (levonorgestrel and ethinyl estradiol) are excreted in breast milk. Active substances are metabolized in the liver, T1/2 is 2-7 hours.
Levonorgestrel is excreted by the kidneys (60%) and through the intestines (40%); ethinyl estradiol - by the kidneys (40%) and through the intestines (60%).

INDICATIONS FOR USE

Oral contraception, functional disorders of the menstrual cycle (including dysmenorrhea without an organic cause, dysfunctional metrorrhagia, premenstrual syndrome).

CONTRAINDICATIONS

Hypersensitivity to the components of the drug, pregnancy, breastfeeding, severe liver diseases, congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndromes), cholecystitis, presence or history of severe cardiovascular and cerebrovascular changes, thromboembolism and predisposition to them , liver tumors, malignant tumors, primarily breast or endometrial cancer; familial forms of hyperlipidemia, severe forms of arterial hypertension, severe forms of diabetes mellitus and other diseases of the endocrine glands, sickle cell anemia, chronic hemolytic anemia, hydatidiform mole, age over 40 years, vaginal bleeding of unknown etiology, migraine, otosclerosis; history of idiopathic jaundice of pregnant women, severe itching of the skin of pregnant women, herpes of pregnant women.

CAREFULLY

Liver and gallbladder diseases, epilepsy, depression, ulcerative colitis, uterine fibroids, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles).
In the presence of diabetes mellitus, diseases of the cardiovascular system, arterial hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, minor chorea, intermittent porphyria, latent tetany, bronchial asthma, the use of the drug also requires caution.

PREGNANCY AND LACTATION

During pregnancy and lactation, taking the drug is contraindicated.

METHOD OF APPLICATION AND DOSES

Apply orally without chewing and with a small amount of liquid.
If hormonal contraception was not used during the previous menstrual cycle, contraception with Rigevidon is started from the first day of menstruation, taking 1 tablet daily for 21 days, at the same time of day.
This is followed by a 7-day break, during which menstrual-like bleeding occurs. The next 21-day cycle of taking tablets from a new package containing 21 tablets must be started the next day after a 7-day break, i.e. on the eighth day, even if the bleeding has not stopped. Thus, the start of taking the drug from each new package occurs on the same day of the week.
When switching to taking Rigevidon from another oral contraceptive a similar scheme is used. The drug is taken as long as the need for contraception remains.
After an abortion, it is recommended to start taking the drug on the day of the abortion or the day after the operation.
After childbirth, the drug can be prescribed only to women who are not breastfeeding; You should start taking the contraceptive no earlier than the first day of menstruation. During lactation, the use of the drug is contraindicated.
Missed pills; The missed tablet should be taken within the next 12 hours. If 36 hours have passed since the last pill was taken, contraception is unreliable. To avoid intermenstrual bleeding, the drug must be continued from the package already started, with the exception of the missed tablet(s). In cases of missed pills, it is recommended to additionally use another, non-hormonal method of contraception (eg, barrier).
For medicinal purposes; The dose of Rigevidon and the regimen of use are selected by the doctor in each case individually.

SIDE EFFECT

The drug is usually well tolerated.
Possible side effects of a transient nature, spontaneously passing: nausea, vomiting, headache, engorgement of the mammary glands, changes in body weight and libido, mood changes, acyclic bleeding, in some cases - swelling of the eyelids, conjunctivitis, blurred vision, discomfort when wearing contact lenses (these phenomena are temporary and disappear after discontinuation without prescribing any therapy).
With long-term use, chloasma, hearing loss, generalized itching, jaundice, calf muscle cramps, and an increase in the frequency of epileptic seizures can very rarely occur. Hypertriglyceridemia, hyperglycemia, decreased glucose tolerance, increased blood pressure (BP), thrombosis and venous thromboembolism, jaundice, skin rashes, changes in the nature of vaginal secretion, vaginal candidiasis, increased fatigue, diarrhea are rarely observed.

OVERDOSE

Cases of toxic effects due to overdose are unknown.

INTERACTION WITH OTHER MEDICINES

Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives can enhance the metabolism of the steroid hormones included in the drug.
A decrease in contraceptive effectiveness can also be observed when administered simultaneously with certain antimicrobial drugs (ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with changes in the microflora in the intestine.
When using anticoagulants, coumarin derivatives or indanedione, it may be necessary to additionally determine the prothrombin index and change the dose of the anticoagulant.
When using tricyclic antidepressants, maprotiline, beta-blockers, their bioavailability and toxicity may increase.
When using oral hypoglycemic drugs and insulin, it may be necessary to change their dose.
When combined with bromocriptine, the effectiveness of bromocriptine is reduced.
When combined with drugs with potential hepatotoxic effects, for example, with the drug dantrolene, increased hepatotoxicity is observed, especially in women over 35 years of age.

SPECIAL INSTRUCTIONS

Before starting contraception and subsequently every 6 months. A general medical and gynecological examination is recommended, including a cytological analysis of a cervical smear, assessment of the condition of the mammary glands, determination of blood glucose, cholesterol and other indicators of liver function, blood pressure monitoring, and urine analysis).
Prescribing Rigevidon to women with thromboembolic diseases at a young age and a family history of increased blood clotting is not recommended.
The use of oral contraception is allowed no earlier than 6 months after viral hepatitis, provided that liver functions are normalized.
If sharp pain appears in the upper abdomen, hepatomegaly and signs of intra-abdominal bleeding, a suspicion of a liver tumor may arise. If necessary, the drug should be discontinued.
If liver function deteriorates while taking Rigevidon, consultation with a physician is necessary.
If acyclic (intermenstrual) bleeding occurs, Rigevidon should be continued, since in most cases this bleeding stops spontaneously. If acyclic (intermenstrual) bleeding does not disappear or recurs, a medical examination should be performed to exclude organic pathology of the reproductive system.
In case of vomiting or diarrhea, the drug should be continued, additionally using another, non-hormonal method of contraception.
Women who smoke and take hormonal contraceptives have an increased risk of developing vascular diseases with serious consequences (myocardial infarction, stroke). The risk increases with age and depending on the number of cigarettes smoked (especially in women over 35 years of age).
The drug should be stopped in the following cases:
- when a migraine-like headache appears for the first time or worsens, or when an unusually severe headache appears;
- when early signs of phlebitis or phlebothrombosis appear (unusual pain or swelling of the veins in the legs);
- if jaundice or hepatitis without jaundice occurs;
- for cerebrovascular disorders;
- when there is stabbing pain of unknown etiology when breathing or coughing, pain and a feeling of tightness in the chest;
- with acute deterioration of visual acuity;
- if thrombosis or heart attack is suspected;
- with a sharp increase in blood pressure;
- when generalized itching occurs;
- with increased frequency of epileptic seizures;
- 3 months before the planned pregnancy, approximately 6 weeks before the planned surgical intervention, with prolonged immobilization.
- if you are pregnant.

INFLUENCE OF THE DRUG ON THE ABILITY TO DRIVE A CAR AND OTHER MECHANISMS
Taking the drug does not affect the ability to drive a car or operate other machinery, the operation of which is associated with an increased risk of injury.

RELEASE FORM

Pills;
21 tablets in a blister made of PVC/PVDC film and aluminum foil;
1 or 3 blisters in a cardboard box with instructions for use.

STORAGE CONDITIONS

At a temperature of 15-30 °C.
The drug must be stored out of the reach of children!

BEST BEFORE DATE

5 years. Do not use after expiration date.

CONDITIONS OF VACATION FROM PHARMACIES

On prescription.

MANUFACTURER

JSC "Gedeon Richter"
1103 Budapest, st. Demrei, 19-21, Hungary.
Consumer complaints should be sent to:
Moscow Representative Office of JSC Gedeon Richter

"Rigevidon" is one of the very first and cheapest oral contraceptives. It has its advantages and disadvantages, but its popularity does not decrease among doctors and women. Instructions for use of "Rigevidon" fully disclose all the nuances of its use. What effect can be expected from the medicine and who is the contraceptive suitable for?

• 1 Features of the medicine
  • 1.1 Operating principle
  • 1.2 Benefits
• 2 Instructions for use of "Rigevidon"
  • 2.1 If the scheme is violated
• 3 What could be the consequences?
  • 3.1 Who is prohibited from receiving
• 4 What will your period be and when to expect it?
• 5 Analogues
• 6 Reviews and results

Rigevidon belongs to the group of monophasic oral contraceptives. This means that each tablet contains the same amount of hormones - estrogen and progestogen - for all days of hormonal therapy. But in addition to this, Rigevidon contains divalent iron, which helps to avoid a drop in hemoglobin during heavy periods.

Features of the medicine

"Rigevidon" includes the following hormones:

• estrogenic component- ethinyl estradiol at a dosage of 30 mcg;
• progestational component- levonorgestrel in a dosage of 150 mcg.

In the “21+7” package, the red tablets contain divalent iron. Taking them allows you to replenish blood loss. This is especially true for women with heavy menstruation, for example, with endometrial hyperplasia or endometriosis, uterine fibroids. If the package contains only 21 tablets, there is no iron in the composition.

Operating principle

"Rigevidon" affects the central nervous system and female genital organs like all other drugs in the series of hormonal contraceptives. Namely:

• levonorgestrel- suppresses the growth and maturation of a new follicle, as a result of which ovulation cannot occur;
• ethinylestradiol- affects the cervical mucus, thickening it and thereby creating a mechanical obstacle to the advancement of sperm.

Against the background of such hormonal changes, the endometrium inside the uterine cavity becomes thinner. This prevents implantation (attachment) of the fertilized egg to the wall in the event of fertilization (for example, if the pill taking schedule is violated). It also ensures less heavy periods. Sometimes they present only as spotting for three to five days.

Advantages

The main purpose of Rigevidon is contraception. But at the same time, it can have a therapeutic effect, so it is often prescribed after surgical interventions, after termination of pregnancy, to stabilize hormonal levels. "Rigevidon" has the following properties:

• reduces the likelihood of developing a repeat ectopic pregnancy;
• reduces the incidence of functional ovarian cysts;
• prevent stagnation of venous blood in the pelvis;
• the drug contains iron in the dummy tablets.

Based on the principles of action of the drug, indications for the use of Rigevidon are established. Namely:

• after surgery for ectopic pregnancy;
• with surgical removal of an ovarian cyst;
• after successful conservative treatment of functional ovarian cysts;
• for endometriosis as the main treatment;
• for contraception;
• after abortions, miscarriages, childbirth;
• for the prevention of anemia with a tendency to heavy periods;
• can be used to stop bleeding, especially in teenage girls.

After taking Rigevidon, menstruation is quickly restored, there is no excessive suppression of the ovarian function. This is done due to a break in taking pills, during which hormones are released by the ovaries and the pituitary gland of the brain.

Instructions for use of "Rigevidon"

Contraceptive pills "Rigevidon" should be taken according to generally accepted instructions for oral contraceptives. There are no documented cases of drug overdose. The admission rules are as follows:

• from the first day of menstruation;
• at the same strictly fixed time;
• for 21 days with a seven-day break (or 28 without a break in the “21+7” package).

Depending on the clinical situation, regimens for taking Rigevidon may differ slightly.

• After similar medications. If a girl decides to switch to the drug from other oral contraceptives, taking Rigevidon should begin immediately after finishing the old pills.
• After patches, rings. If transdermal patches or a vaginal ring were previously used for contraception, Rigevidon must be taken on the day the previous method of contraception is removed.
• After pregnancy. If the interruption (for example, after an abortion or miscarriage) occurs early, the drug should be started on the same day or the next. If a woman decides to take Rigevidon after childbirth, this can be done already on the 28th day, taking into account the fact that lactation is not supported, since the drug actively penetrates into breast milk. After long-term miscarriages (after 16 weeks), you should start taking the first pill on day 28, or earlier if necessary.

The drug is not used to terminate pregnancy, it only prevents conception and implantation of the fertilized egg, so there is no point in starting to take it immediately after unprotected sex, without taking into account the day of the cycle.

If you violated the scheme

In the case where one tablet is missed, it is necessary to determine how much time has passed. Further actions proceed from this:

• up to 36 hours- in this case, you must take the missed tablet and take the next one at the usual time;
• more than 36 hours- in this case, there is no point in taking the missed pill, you only need to take the next one according to the schedule; but in the next week you should use additional methods of contraception, for example, a condom.

To shorten the length of your menstrual cycle and delay your period, you can start the next pack without taking dummy pills. But it is recommended to do this no more than two or three cycles in a row, otherwise the risk of breakthrough bleeding increases.

What could be the consequences?

The side effects of Rigevidon are mild and usually disappear on the second or third package. The main ones include the following:

• headache;
• excessive fatigue;
• irritability;
• nausea;
• weight gain by 1-2 kg;
• decreased sexual desire for a partner;
• liver enzymes may increase in tests;
• sometimes there is dryness of the genital organs, a tendency to thrush.

If a woman decides to take Rigevidon without interruption for several years, it is necessary to regularly monitor the indicators of general and biochemical blood tests to prevent serious complications.

Who is prohibited from receiving

Rigevidon is not an absolutely safe drug. He has a list of contraindications. The main ones include the following:

• disruption of the liver and bile ducts;
• severe arterial hypertension;
• with ever recorded migraine attacks;
• with a history of jaundice or pregnancy itching in a woman;
• for epilepsy and mental illness;
• for thrombosis and thrombophlebitis in a woman and even her close relatives.

It is also not recommended to take it after 40 years and especially during menopause, while smoking, or with unspecified bleeding from the vagina. It is not the drug of choice in adolescents whose menstrual cycle is not yet established.

What will your period be and when to expect it?

After taking Rigevidon, your period does not always come on time and there are no failures. The body needs time to get used to the supply of sex hormones from the outside in a constant amount. After all, they are usually released in a pulsed mode and the readings differ significantly even during the day.

Regular menstrual-like discharge should normally appear after stopping active pills or when taking pacifiers. But this does not always happen, and this is allowed. Most often, various disorders occur in the first two to three months of taking oral contraceptives. The following deviations are possible.

• Start of menstruation while still on active pills. In this case, it is necessary to continue taking it until the end of the package or, when spotting begins, take a seven-day break with pacifiers.
• Delay after whole package. Sometimes in the first two to three months while taking pacifiers, there may be no bleeding, there is nothing pathological in this, but for control you should be examined by a doctor and be sure to rule out pregnancy (especially if there is nausea, engorgement of the mammary glands).
• Spotting throughout the entire cycle. While the body gets used to the new regime, light brownish discharge may periodically appear.
• Scanty discharge instead of menstruation. Very often, while taking hormonal drugs, menstruation becomes very scanty and sometimes presents only spotting, this is normal.
• Bleeding on any day of the cycle. In this case, it is better to immediately consult a doctor to prescribe treatment or discontinue the drug; in parallel, you can take any hemostatic drugs (Etamzilat, Ditsinon, Vikasol, Ascorutin, Tranexam).

Medicine Rigevidon belongs to the group of combined oral contraceptives. Rigevidon is a monophasic drug, each tablet contains the same amount of estrogen and progestogen components. The drug contains levonorgestrel, a synthetic derivative of 19-nortestosterone, which has an activity similar to endogenous progesterone, but exceeds it in potency, which allows the use of levonorgestrel in minimal doses. In addition, the drug contains ethinyl estradiol, a synthetic analogue of endogenous estradiol. The drug effectively prevents pregnancy, the Pearl index is 0.1-0.9. When using the drug, a number of changes occur in a woman’s body that help prevent unwanted pregnancy, including suppression of ovulation, an increase in the viscosity of cervical mucus, and a decrease in the susceptibility of the endometrium to the blastocyst.
The mechanism of action of the drug is based on the pharmacological properties of the active components included in its composition. Thus, the drug blocks the release of releasing factors of the hypothalamus (luteinizing and follicle-stimulating hormone), inhibits the secretion of gonadotropic hormones by the pituitary gland, as a result of which the maturation of the follicle and its rupture slow down. Thus, the active components of the drug inhibit ovulation, preventing fertilization and pregnancy. In addition, the gestagenic component of the drug - levonorgestrel - helps to increase the viscosity of the cervical secretion, as a result of which it is difficult for sperm to penetrate into the uterine cavity, and also, by changing the structure of the endometrium, prevents the implantation of a fertilized egg.

In addition to the contraceptive effect, the drug, when used regularly, helps reduce the risk of developing various gynecological diseases (including reducing the risk of developing functional ovarian cysts, fibroadenomas and fibrocysts in the mammary glands, congestion in the pelvic organs) and reduces the frequency of dysmenorrhea and the amount of blood loss during menstruation. After a course of taking the drug, the risk of ectopic pregnancy decreases. Even after long-term use of the drug, fertility is fully restored within 1-3 cycles after discontinuation of the drug.
Part drug Rigevidon includes placebo tablets (7 placebo tablets per 21 tablets containing active substances) which, due to the content of iron salts, prevent the development of anemia, and also, due to the absence of hormones in them, help to increase the level of follicle-stimulating hormone in the body, which is necessary for the selection of a dominant follicle . Thus, when using the drug Rigevidon“hyperinhibition” syndrome does not develop.

The pharmacokinetics of the drug is based on the pharmacokinetic properties of the active components included in its composition:
Ethinyl estradiol after oral administration is rapidly absorbed from the gastrointestinal tract. Its bioavailability reaches 48%. The peak concentration of the active substance in the blood plasma is observed 1-1.5 hours after oral administration. After absorption into the bloodstream, ethinyl estradiol binds to plasma proteins, mainly albumin, a small part is in an unbound state. The first stage of metabolism occurs in the intestinal walls, the second in the liver, the most significant metabolites of ethinyl estradiol are OH-ethinyl estradiol and 2-methoxy-ethinyl estradiol. It is excreted both unchanged and in the form of metabolites in urine (about 40%) and feces (about 60%). The half-life is approximately 26 hours.
Levonorgestrel is well absorbed from the gastrointestinal tract, bioavailability is 100%. In blood plasma it binds predominantly to globulin and albumin. Metabolized in the body to form sulfate and glucuronide conjugates. Excreted in the form of metabolites in urine and feces.

Indications for use

The drug is used as a means of contraception in women of childbearing age.
The drug can also be prescribed for the correction of functional disorders of the menstrual cycle, including dysmenorrhea, functional uterine bleeding, severe pain that develops in the middle of the cycle, and premenstrual syndrome.
The drug is recommended for use in women with a moderately predominant estrogen phenotype.

Mode of application

Before prescribing the drug Rigevidon A general clinical and gynecological examination should be carried out, which must necessarily include blood pressure monitoring, determination of glucose levels in the urine, general blood and urine analysis, monitoring of liver function, consultation with a mammologist and cytological analysis of smears.
The drug is taken orally, it is recommended to swallow the tablet whole, without chewing or crushing, with a sufficient amount of water. To achieve maximum effect, the drug should be taken at the same time of day.
As a contraceptive, the drug is prescribed 1 white tablet once a day, starting from the first or fifth day of menstruation.

The duration of the course of taking white tablets is 21 days, after which you should take 1 red-brown tablet once a day for 7 days. During the period of taking red-brown tablets, a woman experiences menstrual-like bleeding. If further contraception is necessary, after stopping taking the red-brown tablets, continue taking the drug according to the same regimen. You should not take a break between courses of taking the drug (a full course lasts 28 days - 21 white tablets and 7 red-brown tablets). The start of a new course should occur 4 weeks after the start of the previous one, on the same day of the week.
If you switch to taking the drug Rigevidon after using another oral contraceptive, you should take the first white tablet on the first day of menstruation, and then take the drug according to the regimen described above.
If the drug is well tolerated, it can be taken for as long as there is a need for contraception.

After an abortion, the drug is prescribed as soon as possible after the operation, but no later than the next day after the abortion.
The drug can be prescribed to women after childbirth, if they are not breastfeeding. In this case, taking the drug should begin no earlier than the first day of menstruation.
If you missed taking the next pill, you should take the drug as soon as possible, however, if 36 hours or more have passed between doses of the drug, the effectiveness of the drug is significantly reduced and it is recommended to use an additional barrier method of contraception. To prevent the development of intermenstrual bleeding, you should continue taking the drug from the already started package, eliminating the missed tablet. If you miss a red-brown tablet, additional contraception is not required, since the red-brown tablets do not contain hormones. If vomiting or diarrhea develops when taking white tablets, the contraceptive effect of the drug may be significantly reduced Rigevidon, in this case, an additional non-hormonal method of contraception should be used.
When prescribing a drug for the treatment of functional disorders of the menstrual cycle, the duration of the course of treatment and the dose of the drug are determined by the attending physician individually for each patient.
With long-term use of the drug, patients should undergo a gynecological examination every six months; patients with impaired liver function should undergo control examinations every 2-3 months.
If after finishing taking the white tablets no menstrual bleeding occurs within 7 days, then continuing to take the drug is possible only after pregnancy has been ruled out.

Side effects

The drug is usually well tolerated, however, in some cases the following side effects may develop:
Side effects that develop mainly at the beginning of taking the drug and disappear within 1-3 courses:
From the gastrointestinal tract: nausea, vomiting, dyspepsia.
From the central and peripheral nervous system: headache, emotional lability, increased fatigue, irritability, cramps of the calf muscles. In addition, it is possible to both increase and decrease libido.

Others: breast engorgement, skin rash, intermenstrual bleeding, discomfort when wearing contact lenses.
Side effects that may occur with regular use of the drug:
Impaired glucose tolerance;
Hyperpigmentation of facial skin;
Changes in body weight (both increase and decrease in body weight are possible);
Increased concentration of triglycerides in the blood;
Arterial hypertension;
Thrombosis and thromboembolism of various locations (the risk of developing this side effect is higher in patients over 35 years of age, as well as in women who smoke);
Hepatitis, dysfunction of the gallbladder and biliary tract, diarrhea;
Alopecia;
Changes in vaginal secretion, fungal infections of the vaginal mucosa;
In addition, due to the fact that the red-brown tablets contain ferrous fumarate, stool may turn black.
If acute pain develops in the upper abdomen, it is necessary to exclude the presence of a liver tumor.

Contraindications

Increased individual sensitivity to the components of the drug.
Severe liver dysfunction, Dubin-Johnson syndrome and Rotor syndrome (congenital increase in the level of bilirubin in the blood), stones in the gall bladder, cholecystitis. Hepatitis, including those suffered within 6 months before prescribing the drug (prescribing the drug 6 months after hepatitis, is possible only if liver function is normalized).
Chronic colitis.
Severe diseases of the cardiovascular system, thromboembolism, cerebrovascular and oncological diseases, including a history.
Lipid metabolism disorders.
Severe arterial hypertension.
Diseases of the endocrine system, including diabetes.
Blood system disorders, including chronic hemolytic anemia and sickle cell anemia.
The drug is not prescribed to patients with vaginal bleeding of unknown origin.
Rigevidon Contraindicated in patients suffering from migraines and otosclerosis, including those who have experienced hearing impairment during previous pregnancies.
The drug should not be prescribed to patients with a history of idiopathic jaundice of pregnancy, as well as herpes and severe pruritus of pregnancy.

The drug is contraindicated in women whose close relatives have bleeding disorders and thromboembolism at a young age.
Taking the drug should be stopped 6 weeks before a planned surgical intervention, as well as in the event of pregnancy, with the development of thrombosis, thromboembolism and thrombophlebitis.
In addition, the drug should be discontinued if cerebrovascular disorders, myocardial infarction, visual impairment, retinal thrombosis, diplopia and exophthalmos develop.
Further use of the drug as a means of contraception is not recommended in the event of repeated severe headaches and the development of severe chronic diseases of various localizations.
The drug should be used with caution in women over 40 years of age, as well as with increased load on the vocal cords, and with diseases of the liver and biliary tract.
Prescribed with caution to patients with uterine fibroids, mastopathy and girls in adolescence, in the absence of regular ovulatory cycles.
In addition, caution should be exercised when prescribing the drug to patients suffering from epilepsy (including a history), depression, tuberculosis, ulcerative colitis, varicose veins, phlebitis, multiple sclerosis and kidney disease. Caution should also be exercised with intermittent porphyria, tetany and bronchial asthma.

Pregnancy

The drug is contraindicated for use during pregnancy. Before prescribing the drug, pregnancy should be excluded. You should stop taking the drug Rigevidon at least 3 months before the planned pregnancy, during this period a non-hormonal method of contraception should be used.
The drug is not used during breastfeeding, since its active components are excreted in breast milk. The use of the drug is possible only if the woman is not breastfeeding and has already had menstruation after childbirth.

Interaction with other drugs

When using the drug simultaneously with antimicrobial drugs, including ampicillin, rifampicin, chloramphenicol, phenoxymethylpenicillin, sulfonamides, tetracyclines and neomycin, the contraceptive effect of the drug may be reduced Rigevidon. If it is necessary to use these drugs, it is recommended to use a non-hormonal method of contraception or use barrier contraception, such as a condom, in addition to Rigevidon.
Dihydroergotamine, tranquilizers, phenylbutazone reduce the effectiveness of hormonal contraceptives.
With simultaneous use of the drug with anticoagulants, a group of coumarin derivatives or indanedione, it is possible to increase the effectiveness of the latter. When using these drugs simultaneously, the prothrombin time should be monitored and, if necessary, the dose of anticoagulants should be adjusted.

With the combined use of beta-blockers, maprotiline and tricyclic antidepressants with the drug Rigevidon There is an increase in the bioavailability and toxicity of these drugs.
When using the drug simultaneously with hypoglycemic oral drugs and insulin, it is necessary to monitor blood sugar levels and, if necessary, adjust the dose of insulin and oral hypoglycemic drugs.
When used in combination, the drug reduces the effectiveness of bromocriptine.
The drug, when used simultaneously with drugs that have a hepatotoxic effect, increases their toxicity (the risk of developing hepatotoxicity with this combination is highest in women over 35 years of age).
When prescribing iron supplements, the iron content in red-brown tablets should be taken into account.

Overdose

Currently, cases of drug overdose Rigevidon not reported. If the drug is taken in doses significantly higher than recommended, patients may develop headache, nausea, vomiting, pain in the epigastric region and vaginal bleeding.
There is no specific antidote. In case of overdose, discontinuation of the drug, gastric lavage and administration of enterosorbents are indicated. If necessary, carry out symptomatic therapy.

Release form

Film-coated tablets, 28 pieces in a blister pack, 1 or 3 blister packs in a cardboard box. Each blister contains 21 film-coated tablets, white and 7 film-coated tablets, red-brown.

Storage conditions

It is recommended to store the drug in a dry place away from direct sunlight at a temperature not exceeding 30 degrees Celsius.
Shelf life - 5 years.

Compound

1 film-coated, white tablet contains:
Ethinyl estradiol - 30 µg;
Levonorgestrel - 150 mcg;

1 film-coated, reddish-brown tablet contains:
Iron fumarate - 76.05 mg;
Excipients, including lactose monohydrate and sucrose.

Main settings

Name:	RIGEVIDON
ATX code:	G03AA07 -

Rigevidon is produced in tablets, packaged in blisters of 21 pieces, 3 or 1 blister per package.

pharmachologic effect

Rigevidon tablets exhibit contraceptive action.

Pharmacodynamics and pharmacokinetics

This oral monophasic combined estrogen-progestogen contraceptive drug can have an inhibitory effect on the pituitary production of gonadotropins.

In this case, the contraceptive effect is associated with several mechanisms. Progestin component progestin includes a derivative of 19-nortestosterone known as levonorgestrel . This substance is more active than the corpus luteum hormone or its synthetic analogue pregnin , which has an effect at the receptor level without being affected.

The estrogenic component ethinyl estradiol leads to a blockade of the release of releasing hormones by the hypothalamus and inhibition of the production of gonadotropic hormones by the pituitary gland. At the same time, the maturation and release of the egg, ready for fertilization, is inhibited.

It has been established that ethinyl estradiol enhances the contraceptive effect of the drug. The increased viscosity of the cervical mucus remains, which makes it difficult for sperm to penetrate.

Also, regular use of the drug leads to normalization of the menstrual cycle and prevents the development of certain gynecological diseases, for example, tumors.

Inside the body, the drug undergoes rapid absorption. The concentration of Rigevidon depends on the dosage of the drug and the duration of use. In this case, the maximum concentration is usually detected after 2 hours, elimination occurs on average within 16 hours. The drug is excreted unchanged and unchanged through the intestines and kidneys.

Indications for use

• oral contraception;
• functional disorders of the menstrual cycle, for example, unidentified , dysfunctional metrorrhagia, .

Contraindications

Birth control pills Rigevidon are not prescribed for:

• sensitivity to the drug;
• , ;
• severe liver diseases;
• congenital hyperbilirubinemia;
• thromboembolism;
• tumor diseases;
• severe forms arterial hypertension;
• and other diseases of the endocrine glands;
• sickle cell anemia ;
• chronic hemolytic anemia;
• hydatidiform mole;
• over 40 years of age;
• otosclerosis.

Also, the drug is contraindicated for use in case of bleeding of various origins, idiopathic jaundice, and in pregnant women.

Rigevidon is prescribed with caution to patients with diseases of the liver, kidneys and gall bladder, , ulcerative, mastopathy, , diseases of the cardiovascular system, arterial hypertension, renal dysfunction, , phlebitis , otosclerosis and absent-minded . Caution is also required when prescribing tablets to adolescent patients.

Rigevidon during pregnancy and lactation

It has been established that the use of this drug is contraindicated during pregnancy and lactation.

Side effects of Rigevidon

Usually this drug is well tolerated by patients, but sometimes side effects of Rigevidon occur, which develop transiently and disappear spontaneously. For example, nausea, vomiting, weight gain And libido change , moods, manifestation of acyclic bleeding, conjunctivitis , vision problems and so on.

In rare cases, long-term use of the drug causes chloasma, hearing loss, jaundice, generalized seizures, convulsions, frequency of epileptic seizures, hypertriglyceridemia , hyperglycemia , increased blood pressure, thrombosis or venous thromboembolism, skin rashes, changes in vaginal secretion, high fatigue, etc.

Rigevidon tablets, instructions for use (Method and dosage)

When hormonal contraception was not used during the previous menstrual cycle, it should be started on the 1st day of menstruation. Then you need to take one tablet every day for 21 days, preferably at a certain time of day.

After this, a break of 7 days is taken, during which menstrual-like bleeding occurs. For the next 21 days, the tablets are taken from a new package, that is, already on the 8th day, regardless of whether the bleeding has stopped or not.

The transition to these contraceptive pills from another contraceptive is carried out according to the same scheme. You can take the drug as long as you need it.

The use of the drug for medicinal purposes requires individual selection of dosage and therapeutic regimen.

Overdose

There have been no cases of overdose with Rigevidon.

Interaction

Combination with barbiturates, antiepileptic drugs, for example, and, as well as sulfonamides, pyrazolone derivatives can lead to increased metabolism of the drugs contained in the drug.

The combined use of Rigevidon and certain antimicrobial drugs can reduce the contraceptive effect: , Polymyxin B , sulfonamides and, since they change the composition of the intestines.

This drug may increase the bioavailability and toxicity of tricyclic antidepressants, beta-blockers and A , reduce efficiency.

Combined use with hypoglycemic drugs and often requires changing their dosage. When taken with the drug Dantrolene it is possible that its hepatotoxicity may increase, mainly in women over 35 years of age.

special instructions

Before starting to take contraceptive pills, and every six months when using them, it is necessary to undergo a general medical and gynecological examination. It usually includes a cytological analysis, examination of the mammary glands, assessment of blood glucose, liver function, pressure and urine composition.

For patients who have undergone viral hepatitis and their liver functions have normalized, the drug is prescribed no earlier than 6 months from the moment of recovery.

If sharp pain appears in the abdominal cavity, and signs intra-abdominal bleeding , then this may indicate a liver tumor. If necessary, the drug is immediately discontinued.

Appearance intermenstrual bleeding does not require discontinuation of the contraceptive, since they usually stop on their own. When this does not happen, consultation with a gynecologist is necessary.

As is known, women who smoke when taking hormonal contraceptives can develop vascular diseases with serious consequences - myocardial infarction

There are many reviews of women taking one of these drugs for a long time. This did not lead to the development of undesirable effects, such as changes in libido or weight gain. Moreover, immediately after discontinuation of these contraceptives, pregnancy occurred almost immediately. Therefore, the selection of such drugs must be carried out taking into account individual characteristics after consultation with a gynecologist.

Alcohol and Rigevidon

There have been cases of decreased effectiveness of this drug when alcohol is consumed in large quantities.