FaLessa Kit is a combination contraceptive containing 2 female hormones (levonorgestrel and ethinyl estradiol) that are used to prevent ovulation.
Contents:
Indications for use
- Oral contraception.
Mechanism of action
The contraceptive suppresses ovulation, blocking the release of FSH and LH in the pituitary gland, promotes the secretory transformation of the endometrium, increases the viscosity of cervical mucus, which prevents the penetration of spermatozoa. The sequential intake of birth control pills containing levonorgestrel and ethinyl estradiol makes it possible to replenish and maintain concentrations of these hormones in the blood that are close to physiological, followed by normalization of the menstrual cycle.
Dosage and mode of application
Tablets should be taken every day according to the order indicated on the blister, approximately at the same time, with a small amount of water. Take 1 tablet a day for 28 days in a row. Menstrual bleeding usually occurs in the period of taking inert tablets. As a rule, it begins on the 3rd day after the last active tablet was taken. Begin the next package without breaks.
How to start taking FaLessa Kit?
If you did not use hormonal contraceptive drugs in the previous month:
You must start taking pills on the 1st day of your menstrual period. You can start taking pills on the 5th day of your period, but in this case, it is recommended that you also use the barrier method of contraception in the first 7 days during the first cycle.
Switching from another combination oral contraceptive:
It is recommended to start taking FaLessa Kit the day after taking the last active pill of the previous contraceptive.
Switching from a progestogen-only method (mini-pills, injection, implants) or intrauterine system with progestogen:
You can start taking birth control pills any day after canceling mini-pills (in the case of an implant or intrauterine system – on the day they are removed, in the case of an injection – instead of the next injection). Nevertheless, in all cases, it is recommended that you use an additional barrier method of contraception in the first 7 days during the first cycle.
After an abortion in the I trimester of pregnancy:
You can start taking tablets immediately after an abortion. In this case, there is no need for additional contraceptives.
After childbirth or abortion in the II trimester of pregnancy:
If you are breastfeeding, see the “Pregnancy and Breastfeeding” section.
It is recommended to start taking birth control pills on the 21-28 day after childbirth or abortion in the second trimester of pregnancy. At a later start of the drug, the barrier method of contraception should also be used in the first 7 days. However, if you have already had sexual intercourse, you must exclude a possible pregnancy or wait for menstruation before taking tablets.
Overdose
An overdose of FaLessa can cause dyspepsia, metrorrhagia. There is no antidote. Therapy is selected depending on the symptoms.
Side effects
FaLessa Kit can cause the following side effects: nausea, vomiting, headache, breast engorgement, weight gain, decreased libido and mood, coarsening of the voice, intermenstrual bloody discharge, eyelid edema, conjunctivitis, visual impairment, discomfort when wearing contact lenses.
With long-term contraception and in rare cases, the drug can cause chloasma, hearing loss, generalized itching, jaundice, calf muscle cramps, an increase in epileptic frequency seizures, an increase in plasma triglyceride, glucose, decreased glucose tolerance, increased blood pressure, thrombosis and venous thromboembolism, skin rashes, a changed nature of the vaginal secretions, vaginal candidiasis, fatigue.
Contraindications
FaLessa Kit is contraindicated in the following conditions/diseases:
- hypersensitivity to levonorgestrel / ethinyl estradiol or other ingredients of the drug;
- hepatic insufficiency, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson and Rotor syndrome);
- liver tumors (hemangioma, liver cancer);
- malignant tumors (primarily breast cancer or endometrium);
- the presence or a history of severe cardiovascular and cerebrovascular diseases;
- thromboembolism and predisposition to it (ischemic or hemorrhagic stroke, widespread atherosclerosis, decompensated heart diseases, myocarditis, decompensated heart failure, severe forms of hypertension);
- diabetes mellitus of severe course (accompanied by retinopathy and microangiopathy);
- sickle-cell anemia, chronic hemolytic anemia;
- vaginal bleeding of unknown etiology;
- migraine;
- otosclerosis, otosclerosis with hearing impairment;
- bladder skidding;
- idiopathic jaundice or pruritus during the previous pregnancy.
With caution:
- obesity;
- smoking;
- hemolytic uremic syndrome;
- systemic lupus erythematosus;
- age more than 35 years;
- otosclerosis in a history of pregnancy;
- idiopathic jaundice in a history of pregnancy;
- thrombophlebitis of superficial veins;
- itching during pregnancy in anamnesis;
- Dubin-Johnson syndrome;
- hyperlipidemia;
- thromboembolism related to the use of oral contraceptives in anamnesis;
- migraines;
- Gilbert’s syndrome;
- diabetes mellitus;
- Crohn’s disease;
- sickle cell anemia;
- Rotor syndrome;
- arterial hypertension.
Interactions
The joint intake of FaLessa Kit with certain drugs can cause the following effects:
- Drugs that induce liver enzymes (long-term therapy): breakthrough bleeding and/or a decrease in the contraceptive efficacy;
- Pyrazolone derivatives, sulfonamides: enhance the metabolism of levonorgestrel and ethinyl estradiol;
- Antibiotics (ampicillin, tetracycline): decrease the contraceptive effect (due to a decrease in the concentration of ethinyl estradiol).
During therapy with estrogen-progestogen drugs, it may be necessary to correct dosages of drugs with hypoglycemic action and indirect anticoagulants. FaLessa Kit can affect the metabolism of other drugs (including cyclosporine), which can change their concentration in tissues and plasma.
Pregnancy and breastfeeding
FaLessa Kit is not indicated for use during pregnancy and breastfeeding. When pregnancy occurs while taking birth control pills, they must be immediately canceled. The conducted studies did not reveal any increased risks of developmental defects in infants born to women who took combined oral contraceptives before pregnancy. Also, studies did not reveal the teratogenic effect of the drug when it was used in the early stages of pregnancy.
The contraceptive can change the composition of breast milk and reduce its amount, so the use of birth control pills is prohibited during the lactation period. Levonorgestrel and ethinyl estradiol can be secreted in small quantities with milk, but there is no confirmed data on their negative impact on the health of the child.
What if I miss a pill?
The contraceptive effect of the drug does not decrease when the delay in taking a daily dose does not exceed 12 hours. In this case, it is necessary to take the missed pill as soon as possible, then return to the usual dosing regimen. If the delay is more than 12 hours, adhere to the following manual:
- Do not interrupt the course of FaLessa Kit for longer than 7 days;
- Conduct a continuous therapy for 7 days to adequately suppress hypothalamic-pituitary-ovarian regulation.
If you miss the daily dose during the first week, the tablet should be taken, even if this means taking two pills at the same time. Next, you need to adhere to the usual scheme of taking the drug, but barrier contraceptive measures should be used for the next 7 days. If you had sexual intercourse during the week before missing pills, you should consider the possibility of pregnancy. The more tablets were missed and the closer this period to the phase of inert tablets, the higher the probability of pregnancy.
If you miss a daily dose of the contraceptive during the second week, the missed tablet should be taken, even if this means taking two pills at the same time. Next, you need to adhere to the usual scheme of taking birth control pills without the use of additional protective measures. If a woman missed other tablets in the previous 7 days, there is a need for additional contraception.
If you miss a dose during the third week, the risk of a decrease in drug safety is inevitable, which is due to the upcoming phase of inert tablets. In this case, you can adhere to one of the following schemes:
- The last missed tablet should be taken as soon as possible (two tablets are taken simultaneously). Then continue the therapy according to the usual scheme. Once you finish taking 21 active tablets from the current package, begin a new one immediately (this means you should skip 7 inert tablets from the current package). Bleeding cancellation, most likely, will occur after you take the last active tablet from the second package, but you may also have spotting and breakthrough bleeding between periods;
- Stop taking pills from the current package for 7 days (including the day of missing a dose), then continue the therapy with tablets from a new package.
If you missed a single dose and bleeding cancellation did not occur during a phase of taking inert tablets, you need to exclude pregnancy.
If you miss a dose during the fourth week, discard the missed tablets since they are inactive and contain no hormones.
Precautions
If you use drugs that affect microsomal enzymes, you need to use additional birth control methods within 4 weeks after their withdrawal.
If it is necessary to take ampicillin or tetracycline, you need to use additional birth control methods for 7 days after the course of antibiotics is completed.
Do not take a break between the packs of FaLessa Kit even if your menstruation has not stopped.
If you had vomiting or diarrhea (indigestion) within 3-4 hours after taking an active tablet, the ingredients may not have been fully absorbed. This situation is similar to missing a pill. Therefore, follow the instructions for missed pills.
The patient should be warned about the risks and complications associated with taking combination oral contraceptives. When unusual symptoms appear, consult a doctor as soon as possible.
Irregular bleeding within the first three months of taking birth control pills does not require the drug cancelation.
The medication does not protect a patient from venereal diseases, HIV infection.
The drug should be discontinued a month before the planned surgery and resumed only after the immobilization has ceased.