Balcoltra is a hormonal contraceptive which is used to prevent pregnancy. The drug contains ethinyl estradiol, levonorgestrel and ferrous bisglycinate.
- Menstrual disorders.
The drug inhibits the secretion of gonadotropic hormones in the pituitary gland, inhibits the maturation of follicles, hampers the ovulation process, reduces the susceptibility of the endometrium to the blastocyst, and increases the viscosity of cervical mucus, making it difficult for sperm to enter the uterus.
In addition to the contraceptive effect, the drug with regular reception has a therapeutic effect, normalizing the period and preventing the development of a number of gynecological diseases.
The high activity of levonorgestrel in very low dosages has no effect on lipid and carbohydrate metabolism and does not have androgenic properties.
The pharmacological action of ferrous bisglycinate is hematopoietic, erythropoietic, anti-anemic. It replenishes the body’s iron deficiency, necessary for the synthesis of hemoglobin.
Balcoltra pack contains 28 tablets: 21 active tablets, each containing 0.10 mg levonorgestrel and 0.02 mg ethinyl estradiol, and 7 inert tablets containing 36.5 mg ferrous bisglycinate.
Take 1 tablet daily at the same time (preferably after breakfast or dinner) for 28 days, starting from the first day of the period (1 day of menstrual bleeding). Menstrual bleeding occurs in the period of taking inert tablets. Continue taking the drug from the next package regardless of whether the bleeding has ended or is just beginning.
Each package should be started on the same day of the week.
After discontinuation of the contraceptive, the functions of the gonads quickly recover, which provides a normal ability to conceive.
After the cessation of treatment, the first period is usually extended by 1 week. If the period is not restored within 2-3 months, it is necessary to consult a doctor.
When switching from other combined oral contraceptives, it is preferable to start taking Balcoltra tablets the day after taking the last active tablet from the previous package, but not later than the next day after taking the last inactive tablet.
If a woman used gestagen-only contraceptives (“mini-pills”), the drug can be started any day (without interruption). After termination of pregnancy in the first trimester, a woman can start taking birth control pills immediately and does not need additional contraceptive measures. After childbirth or termination of pregnancy in the second trimester, the drug should be started no later than the 21st-28th day. Additionally, a woman should use a barrier method of contraception during the first 7 days of taking Balcoltra. In any case, before taking this contraceptive, pregnancy should be excluded.
In some cases, Balcoltra pills can cause the following side effects:
- digestive system: nausea, gastralgia, black staining, darkening of teeth enamel, vomiting, constipation, diarrhea, cholestasis, pancreatitis, jaundice, hepatocellular adenoma;
- reproductive system: a feeling of tension, tenderness of the mammary glands, changes in libido, an increase and discharge from the mammary glands, metrorrhagia during the first few months, changes in vaginal secretion;
- nervous system: headache, anxiety, depression, migraine;
- cardiovascular system: thrombophlebitis, thromboembolism;
- sensory organs: visual impairment, hearing loss;
- other: fluid retention in the body, hyperlipidemia, allergic reactions (skin rash, itching, eyelid edema, conjunctivitis), poor tolerance of contact lenses, change in body weight, impaired metabolism of Na + and Ca2 +, with prolonged use – chloasma (focal pigmentation).
Balcoltra is contraindicated for use in the presence of the following conditions or diseases:
- presence or anamnesis of thrombosis (venous and arterial), deep vein thrombosis of the lower limbs, thromboembolism of the branches of the pulmonary artery, conditions preceding thrombosis (transient ischemic attacks, angina pectoris, myocardial infarction, complicated cardiac valve lesions (pulmonary hypertension, atrial fibrillation, subacute bacterial endocarditis), ischemic or hemorrhagic cerebrovascular disorders), serious surgical intervention with prolonged immobilization;
- severe or multiple risk factors for venous or arterial thrombosis;
- diabetes mellitus with vascular complications (angiopathy, retinopathy);
- jaundice, congenital hyperbilirubinemia (Gilbert syndrome, Dubin-Johnson syndrome and Rotor syndrome), severe forms of liver disease (prior to normalization of liver tests), benign or malignant liver tumors;
- pancreatitis with severe hypertriglyceridemia (including in the anamnesis);
- epilepsy, migraine with focal neurological symptoms (present and in the anamnesis);
- Sickle cell anemia;
- hormone-dependent malignant diseases of genital organs or mammary glands (including in the anamnesis), hyperprolactinaemia, hyperphilicular stage of menopause, inflammatory diseases of female genital organs (salpingoophoritis, endometritis), uterine bleeding of unknown origin;
- pregnancy, lactation;
- hypersensitivity to the components of Balcoltra (ethinyl estradiol, levonorgestrel and ferrous bisglycinate);
- hemolytic (hereditary and acquired) and other anemia, not associated with iron deficiency;
- hemochromatosis, gastric and duodenal ulcer in the exacerbation phase, inflammatory bowel disease (Crohn’s disease, ulcerative colitis).
With caution: excessive body weight, dyslipoproteinemia, diabetes, arterial hypertension, atherosclerosis, varicose veins, renal dysfunction, fibrocystic mastopathy, uterine myoma, migraine, otosclerosis, multiple sclerosis, epilepsy, severe depression in history, porphyria, systemic lupus erythematosus, Sydenham’s chorea, chloasma; intolerance of contact lenses; a family history of thromboembolism, blood clotting disorders, chronic heart failure, strokes, breast cancer.
The relative risk of developing thrombosis increases in women over 35 years of age; with prolonged immobilization, extensive trauma; with peripheral circulatory disorders (tetany, hemolytic uremic syndrome), Crohn’s disease, ulcerative colitis, phlebitis of superficial veins.
- Barbiturates, some antiepileptic medicines (carbamazepine, phenytoin) are able to enhance the metabolism of ethinyl estradiol and levonorgestrel;
- The contraceptive effect of the drug is reduced when taken together with certain antibiotics (ampicillin, rifampicin, tetracycline, griseofulvin);
- Nonsteroidal anti-inflammatory drugs reduce the effectiveness of birth control pills;
- You may need to adjust the dosage regimen for hypoglycemic drugs.
Balcoltra is contraindicated for use during pregnancy and lactation. If you need to use the drug during lactation, you should stop breastfeeding. Ethinyl estradiol and levonorgestrel are excreted in small amounts with breast milk.
- If you missed an active pill containing hormones, it is necessary to take it within the next 12 hours, otherwise, the contraceptive effect in this period may decrease. If the interval exceeds 12 hours, discard a pill and continue taking the drug at the usual time. In these cases, additional barrier methods of contraception should be used to achieve a reliable contraceptive effect;
- If you missed an inert pill, you may discard it and not worry since it contains no hormones.
Before using the drug and every 6 months, a woman should undergo a thorough general medical and gynecological examination, exclude pregnancy and violations of blood coagulation.
Due to the fact that the contraceptive effect of Balcoltra is fully manifested by the 14th day, it is recommended to use additional non-hormonal methods of contraception in the first 2 weeks.
If you have intermenstrual bleeding (spotting) in the first few months of taking birth control pills, the course should not be discontinued. As a rule, spotting stops after the adaptation period (2-3 months). With the recurrence of such secretions, an increase in their intensity, unusually strong and abundant menstrual bleeding, consult a doctor. A consultation is also required if you have no menstrual bleeding after taking the last inert pill in the pack.
Ethinyl estradiol and levonorgestrel may change the usual course of the period, the rectal temperature and the properties of the cervical mucus.
Vomiting or diarrhea within 3-4 hours after taking a pill may reduce its contraceptive effect. In this case, continue taking the drug and use additional non-hormonal methods of contraception.
The drug is canceled 6 weeks before the scheduled surgery and prolonged immobilization and resumed 2 weeks after the end of immobilization due to an increased risk of thrombus formation.
Discontinue using the drug and consult a doctor if you have any of the following signs: early signs of phlebitis, thrombosis or embolism (unusual pains in the lower limbs along the veins and their swelling, acute pain and a feeling of compression or heaviness in the chest, sudden shortness of breath), permanent itching, severe pain in the lower abdomen, pains and migraines, severe depression, a significant increase in blood pressure, frequent seizures, sudden changes in sight, hearing or speech, first appeared motor disorders, hepatitis, jaundice, cholestasis, porphyria, pregnancy symptoms.
Smoking women have an increased risk of developing vascular diseases. The risk increases with age and the number of cigarettes smoked per day (especially in women over 30 years of age). The risk of thrombosis increases with high blood pressure. Patients with a predisposition to chloasma should avoid exposure to sunlight when using birth control pills.