Rigevidone - instructions for use, dose, side effects, contraindications

- in the core of the tablet: silicon dioxide colloid - 0.275 mg, magnesium stearate - 0.550 mg, talc - 1,100 mg, corn starch - 19,895 mg, lactose monohydrate - 33,000 mg;

- in the tablet shell: sucrose - 22,459 mg, talc - 6,826 mg, calcium carbonate - 3,006 mg, titanium dioxide - 1,706 mg, kopovidone - 0,592 mg, macrogol 6000 - 0.148 mg, silicon dioxide colloid - 0.146 mg, povidone - 0.088 mg, carmellose sodium - 0.029 mg .

Description:

White, round, biconvex tablets, coated.

Pharmacotherapeutic group:Contraceptive agent (estrogen + progestogen)

ATX: & nbsp

G.03.A.B Progestogens and estrogens (combinations for sequential administration)

G.03.A.B.03 Levonorgestrel and ethinyl estradiol

Pharmacodynamics:

Rigevidone is an oral monophasic combined estrogen-progestational drug.

When ingested, depresses the pituitary secretion of gonadotropic hormones. The contraceptive effect is associated with several mechanisms. As a progestogen component (progestin) contains a derivative of 19-nortestosterone - levonorgestrel, surpassing the activity of the hormone of the yellow body progesterone (and synthetic analogue of the latter - pregnin), acts at the level of receptors without preliminary metabolic transformations. The estrogen component is ethinyl estradiol. Under the influence of levonorgestrel comes the blockade of releasing the releasing hormones (LH and FSH) of the hypothalamus, suppressing the secretion of the gonadotrophic hormones by the pituitary gland, which leads to inhibition of maturation and release of the ovum (ovulation) ready for fertilization.The contraceptive effect is enhanced by ethinyl estradiol. Preserves high viscosity of the cervical mucus (making it difficult for sperm to enter the uterine cavity). Along with the contraceptive effect with regular intake normalizes the menstrual cycle and helps prevent the development of a number of gynecological diseases, including. tumor nature.

Pharmacokinetics:

Levonorgestrel quickly absorbed (less than 4 hours). Levonorgestrel has no effect of first passage through the liver. When levonorgestrel is used together with ethinylestradiol, there is a relationship between dose and maximum plasma concentration. TS_m_Oh (time to reach the maximum concentration) of levonorgestrel is 2 h, T_1/2 (half-life) - 8-30 hours, (an average of 16 hours). Most of the levonorgestrel binds in the blood with albumin and SHBG (Globulin, binding sex hormones).

Ethinylestradiol quickly and almost completely absorbed from the intestine. Ethinyl estradiol inherent effect of primary passage through the liver, TC_m_Oh is 1.5 hours, half-life is about 26 hours.

When administered orally ethinyl estradiol is released from the blood plasma for 12 hours, the half-life is 5.8 hours.

Metabolism ethinyl estradiol is carried out in the liver and intestines. Metabolites ethinyl estradiol - water-soluble products of sulfate or glucuronide conjugation, enter the intestines with bile, where they are disintegrated with intestinal bacteria.

Both components (levonorgestrel and ethinyl estradiol) are excreted in breast milk. Active substances are metabolized in the liver, T_1/2 is 2-7 hours. Levonorgestrel is excreted by the kidneys (60%) and through the intestine (40%); ethinyl estradiol - by the kidneys (40%) and through the intestine (60%).

Indications:

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 disease, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome), cholecystitis, history or history of severe cardiovascular and cerebrovascular changes,thromboembolism and predisposition to them, liver tumors, malignant tumors, especially breast cancer or endometrium; family forms of hyperlipidemia, severe forms of arterial hypertension, severe diabetes and other endocrine gland diseases, sickle cell anemia, chronic hemolytic anemia, gall bladder, age over 40 years, vaginal bleeding of unknown etiology, migraine, otosclerosis; idiopathic jaundice of pregnant women in anamnesis, severe pruritus of pregnant women, herpes of pregnant women.

Carefully:

Diseases of the liver and gallbladder, epilepsy, depression, ulcerative colitis, uterine myoma, mastopathy, tuberculosis, kidney disease, adolescence (without regular ovulatory cycles).

In the presence of diabetes, cardiovascular diseases, arterial hypertension, renal dysfunction, varicose veins, phlebitis, otosclerosis, multiple sclerosis, epilepsy, small chorea, intermittent porphyria, latent tetany, bronchial asthma, the administration of the drug also requires caution.

Pregnancy and lactation:During pregnancy and during lactation, taking the drug is contraindicated.

Dosing and Administration:

Use inside, not chewing and squeezed with a small amount of liquid.

If hormonal contraception was not performed during the previous menstrual cycle, to contraception Rigevidon start from the first day of menstruation, taking 1 tablet daily for 21 days, at the same time of day. Then follows a 7-day break, during which menstrual bleeding occurs. The next 21-day cycle of taking tablets from a new package containing 21 tablets should start the day after the 7-day break, that is, on the eighth day, even if the bleeding has not stopped. Thus, the start of taking the drug from each new package falls on the same day of the week.

When switching to taking Rhevidone from another oral contraceptive a similar scheme is used. The drug is taken as long as there is a need for contraception.

After abortion It is recommended to start taking the drug on the day of abortion or the day after the operation.

After childbirth the drug can be administered only to women who do not breast-feed; to take a contraceptive should be started no earlier than the first day of menstruation. During lactation, the use of the drug is contraindicated.

Missed tablets; the missed tablet should be taken within the next 12 hours. If 36 hours have elapsed since taking the last pill, contraception is unreliable. To avoid intermenstrual bleeding, taking the drug should be continued from the package that has already been started, with the exception of the missed tablet (s). In cases of missing tablets, it is recommended to additionally use another, non-hormonal method of contraception (eg, barrier).

For medicinal purposes; The dose of Rigevidone and the scheme of application are selected by the doctor in each case individually.

Side effects:

The drug is usually well tolerated.

Possible side effects of transitory nature, spontaneously passing: nausea, vomiting, headache, breast engorgement, weight and libido change, mood changes, acyclic spotting, in some cases - eyelid edema, conjunctivitis, visual impairment, discomfort with wearing contact lenses (these phenomena are temporary and disappear after withdrawal without prescribing any therapy).

With prolonged admission, chloasma, hearing loss, generalized pruritus, jaundice, calf muscle cramps, and increased frequency of epileptic seizures can very rarely occur. Rarely observed hypertriglyceridemia, hyperglycemia, impaired glucose tolerance, increased blood pressure (BP), thrombosis and venous thromboembolism, jaundice, skin rashes, the changing nature of the vaginal secretions, vaginal candidiasis, fatigue and diarrhea.

Overdose:Cases of toxic effects due to overdose are unknown.

Interaction:

Barbiturates, some antiepileptic drugs (carbamazepine, phenytoin), sulfonamides, pyrazolone derivatives are able to enhance the metabolism of steroid hormones included in the preparation.

Reduced contraceptive efficacy can be observed while the appointment with some antimicrobial drugs (ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines), which is associated with changes in the microflora in the gut.

When using anticoagulants, coumarin or indanedione derivatives, it is possible to further define the prothrombin index and change the dose of the anticoagulant.

With the use of tricyclic antidepressants, maprotiline, beta-blockers may increase their bioavailability and toxicity.

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

Pi combination with bromocriptine decreases the effectiveness of bromocriptine.

When combined with drugs with a potential hepatotoxic effect, eg with dantrolene, there is an increase in hepatotoxicity, especially in women over 35 years of age.

Special instructions:

Before the beginning of contraception and, subsequently, every 6 months. it is recommended to have a general medical and gynecological examination, including cytological analysis of the smear from the cervix, assessment of the mammary glands condition, determination of blood glucose, cholesterol and other liver function parameters, blood pressure control, urinalysis).

The appointment of Rhevidone to women with thromboembolic disease at a young age and an increase in blood coagulability in a family history is not recommended.

The use of oral contraception is allowed no earlier than 6 months after the transferred viral hepatitis, provided normalization of hepatic functions.

When there are sharp pains in the upper abdominal areas, hepatomegaly and signs of intra-abdominal bleeding, there may be a suspicion of a liver tumor. If necessary, the drug should be discontinued.

If the hepatic function worsens during the reception of Rigevidone, the therapist's consultation is necessary.

When acyclic (intermenstrual) bleeding occurs, taking Rigevidone should be continued, as in most cases these bleedings spontaneously cease. If acyclic (intermenstrual) bleeding does not disappear or recur, a medical examination should be performed to exclude the organic pathology of the reproductive system.

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

Smoking women taking 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 older than 35 years).

The drug should be discontinued in the following cases:

- with the appearance of a migraine headache for the first time or augmentation, or the appearance of an unusually severe headache;

- with the appearance of early signs of phlebitis or phlebothrombosis (unusual pain or swelling of the veins on the legs);

- if there is jaundice or hepatitis without jaundice; with cerebrovascular disorders;

- with the appearance of stitching pains of unclear etiology during breathing or coughing, pain and tightness in the chest;

- with acute deterioration of visual acuity;

- with suspected thrombosis or heart attack;

- with a sharp increase in blood pressure;

- when generalized itching occurs;

- with increased epileptic seizures;

- 3 months before the planned pregnancy,

- approximately 6 weeks before the planned surgical intervention,

- with prolonged immobilization.

- in the presence of pregnancy.

Effect on the ability to drive transp. cf. and fur:

Admission of the drug does not affect the ability to drive and other mechanisms, work with which is associated with an increased risk of injury.

Form release / dosage:The tablets covered with a cover, 0,15 mg + 0,03 mg.

Packaging:

21 tablet in a blister of PVC / PVDH-film and aluminum foil. 1 or 3 blisters in a cardboard box with instructions for use.

Storage conditions:At a temperature of ns above 25 ° C. Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012676 / 02

Date of registration:07.09.2007 / 10.06.2015

The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary

Manufacturer: & nbsp

GEDEON RICHTER, Plc. Hungary

Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary

Information update date: & nbsp31.05.2016

Illustrated instructions

Instructions

Rigevidone® (Rigevidon®)