Rigevidon (levonorgestrel, ethinyl estradiol) coated tablets №63

Description

Rigevidon (levonorgestrel, ethinyl estradiol) coated tablets №63

Composition 

active substances: levonorgestrel, ethinylestradiol;

1 film-coated tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg;

Auxiliary substances: colloidal anhydrous silicon dioxide, magnesium stearate, talc, corn starch, lactose monohydrate, carmellose sodium, povidone K-30, polyethylene glycol (macrogol 6000), copovidone, titanium dioxide (E 171), calcium carbonate, sucrose.

Medicinal form

Coated tablets.

Main physicochemical properties: white, round, biconvex, film-coated tablets, 6 mm in diameter.

Pharmacotherapeutic group

Hormonal contraceptives for systemic use. Progestogens and estrogens, fixed combinations.
ATX code G03A A07.

Pharmacological properties

Rigevidon tablets belongs to the group of combined drugs containing hormones secreted by the sex glands, intended for systemic use, with a contraceptive effect.
The use of this drug in this combination has a contraceptive effect. Its effectiveness is due to the fact that the drug has several mechanisms at once that prevent the fertilization of the egg.
The main mechanism of contraceptive action is that the ovulation process is inhibited, as well as the thickening of mucus secreted in the area of ​​the cervical canal of the cervix.

Indications

Rigevidon tablets is used as a hormonal contraceptive.

Contraindications

Not applicable if the patient has hypersensitivity (allergy) to one of the components that make up the drug.
In addition, the use of this drug is contraindicated in:

• breast cancer;
• estrogen-dependent cancers;
• vaginal bleeding of unexplained etiology;
• incurable endometrial hyperplasia;
• venous thromboembolism;
• arterial thromboembolic disorders (eg, angina pectoris, myocardial infarction);
• thrombophilia (eg, protein C, S, or antithrombin deficiency);
• high risk of developing venous or arterial thrombosis;
• liver tumors of any etiology;
• liver diseases, before the normalization of laboratory parameters of the functional state of the liver, cholecystitis, colitis;
• porphyria;
• severe hypertriglyceridemia.

Application during pregnancy and lactation

It is not used to treat pregnant women.
If there is a need to take this drug, then during treatment, lactation (breastfeeding) should be suspended.

Method of administration and dosage

How to take Rigevidon tablets

Internally, in the order indicated on the package, at approximately the same time, drinking a small amount of liquid if necessary.

Use Rigevidon 1 tablet daily during the 21st day. Each subsequent package is started after a 7-day break, during which menstrual-like bleeding usually occurs (usually it begins on the 2-3rd day after taking the last pill and may not end until the start of taking the pill from the next package).

How to start using Rigevidon tablets

If hormonal contraceptives were not used in the previous month

Tablets should be taken on the 1st day of the natural cycle, i.e. on the first day of menstrual bleeding.

Switching from another COC (COC, vaginal ring or transdermal patch)

The use of Rigevidon tablets must be started the day after taking the last active pill of the previous contraceptive, but no later than the day after the break in taking the pills of the previous contraceptive.

The first tablet of the drug should be taken on the day of removal of the vaginal ring or transdermal patch, but no later than the day when a new transdermal patch or ring should be applied.

Switching to Rigevidon tablets from a progestogen-only drug (progestogen-only pills or mini-pill, injection, implant, or progestogen-only intrauterine system)

The transition from the mini pill can be made on any day of the menstrual cycle. Taking Rigevidon should be started the day after stopping the minipill.

Transition from the implant and intrauterine system – on the day of their removal, from the injection – on the day when the next injection should be prescribed.

In all cases, it is recommended to additionally use an additional method of contraception during the first 7 days of taking the pills.

After an abortion in the first trimester of pregnancy

The use of the drug should be started immediately on the same day after the operation. In this case, there is no need to use additional contraceptives.

After childbirth or after an abortion in the II trimester of pregnancy

The use of the drug Rigevidon should be started from the 21st to the 28th day after childbirth and in case of refusal of breastfeeding or abortion in the II trimester of pregnancy, as the risk of developing thromboembolic disorders during the postpartum period increases. If a woman starts taking Rigevidon later, barrier methods of contraception should be additionally used during the first 7 days of taking the drug. However, if sexual intercourse has already taken place, then before starting the use of the drug, you should rule out possible pregnancy or wait for the first menstruation.
What to do if you miss taking pills

The effectiveness of contraception may decrease in the case of skipping pills, especially if the time period between taking the last pill from the current blister pack and the first pill from the next pack increases.

If less than 12 hours have passed since the time when the next pill should have been taken, contraceptive protection is not reduced. A woman should take the missed pill as soon as she remembers it, the next pill should be taken at the usual time.

If more than 12 hours have passed since the time when the next pill should have been taken, contraceptive protection may decrease. In this case, it is necessary to be guided by two basic rules:

1. A break in taking pills can never exceed 7 days.
2. Adequate inhibition of the hypothalamus – pituitary – ovaries system is achieved by continuous taking of tablets for 7 days.

In accordance with the above, the following recommendations should be followed in everyday life:

1st week
The last missed pill should be taken immediately after the woman remembers it, even if you have to take 2 pills at the same time. After that, taking pills continues as usual. In addition, barrier methods of contraception (for example, a condom) should be additionally used for the next 7 days. If during the previous 7 days sexual intercourse took place, the possibility of pregnancy should be taken into account. The more pills are missed and the closer the missed pill is to a 7-day break in the use of the drug, the higher the risk of pregnancy.

2nd week
The last missed pill should be taken immediately after the woman remembers it, even if she has to take 2 pills at the same time. After that, taking pills continues as usual. If a woman has taken pills correctly for 7 days before missing the first pill, there is no need to use additional contraceptives. Otherwise, or if more than one pill is missed, it is recommended to additionally use a barrier method of contraception for 7 days.

3rd week
The risk of a critical decrease in contraceptive protection is inevitable due to the upcoming 7-day break in the use of the drug. However, if you follow the pill regimen, you can avoid a decrease in contraceptive protection. If you follow one of the options below, there will be no need to use additional contraceptives, provided you take the pills correctly for 7 days before the missed period. If this is not the case, it is recommended to follow the first of the following options and use additional barrier methods of contraception (eg condoms) for the next 7 days.

1. The last missed pill should be taken as soon as the woman remembers it, even if 2 pills should be taken at the same time. After that, taking pills continues as usual. The patient should start taking pills from the next package the next day after taking the last pill from the current package, that is, there should be no pause between packages. It is unlikely that a woman will have menstrual-like bleeding before the end of the second pack of pills, although spotting or breakthrough bleeding may occur.

2. The woman can also be advised to stop taking pills from the current package. In this case, the patient should take a break in the use of the drug for up to 7 days, including the days on which she forgot to take pills, and then start taking pills from the next package of the drug.

If a woman misses a pill and then has no menstrual bleeding during the first usual break in the use of the drug, the possibility of pregnancy should be considered.

Recommendations in case of disturbances from the gastrointestinal tract

In the case of severe disorders of the gastrointestinal tract (vomiting or diarrhea), incomplete absorption of the drug is possible, so it is necessary to use additional means of contraception. If vomiting or severe diarrhea occurred within 3-4 hours after taking the pill, you should take a new pill as soon as possible. If possible, the new tablet should be taken no later than 12 hours after the usual time of administration. If more than 12 hours have passed, it is necessary to follow the rules for taking the drug specified in the section “What to do if you miss taking pills.”

If the woman does not want to change her usual regimen of taking the drug, she must take additional pill(s) from a different package.

How to postpone the onset of menstruation or delay menstruation

To delay menstrual bleeding, taking Rigevidon tablets from a new package should be started the day after the end of the current package, without a break between them. During this period, breakthrough bleeding or spotting may occur. Regular use of Rigevidon can be resumed after the usual 7-day break.

To shift the onset of menstruation to another day of the week, the 7-day break in the use of the drug is shortened by the desired number of days.

The shorter the break in the use of the drug, the more likely it is that menstrual-like bleeding will not occur, and breakthrough or spotting bleeding will appear when taking pills from the next package (as in the case of delayed menstruation). It is important to emphasize that the break in the use of the drug cannot be increased.

Children

The drug is not intended for use by children.

Overdose

Overdose cases were not recorded. Theoretically, with an overdose, the following symptoms are possible:

• nausea;
• vomiting;
• a feeling of tension in the mammary glands;
• vaginal bleeding.

It is necessary to wash the stomach, take sorbents, establish monitoring of the patient’s condition, and, if necessary, carry out a complex of standard supportive symptomatic therapy.

Side effects

When using this drug, an adverse reaction may occur in the form of:

• increased blood glucose levels, anemia, changes in body weight, hyperbilirubinemia;
• headache, migraine, memory loss, confusion, dizziness, insomnia;
• visual impairment;
• nausea, vomiting, bloating, abdominal pain, constipation, dyspeptic symptoms, pancreatitis, jaundice, diabetes mellitus;
• acne, seborrhea, itching;
• arterial hypertension, tachycardia, varicose veins, hemorrhoids, other disorders of the cardiovascular system;
• thrombosis, superficial thrombophlebitis, arterial hypotension;
• allergies, weight gain;
• cholangitis, cholecystitis, liver dysfunctions;
• neoplasia of the mammary glands, pain in them;
• anxiety, depression;
• venous thromboembolism.

In case of any side effects, you should consult your doctor.