Setlakin is an extended-cycle contraceptive which contains females hormщnes, known as ethinyl estradiol and levonorgestrel, that are used to prevent pregnancy.
Indications for use
Mechanism of action
Setlakin suppresses ovulation, increases the viscosity of the secretion of the cervix, which makes it difficult for spermatozoa to penetrate into the uterine cavity, and changes the endometrium that prevents the implantation of a fertilized egg.
The drug provides a prolonged protection against unplanned pregnancy since it has no regular “hormone-free” periods. The drug also improves well-being due to a reduction in the number of menstruations and symptoms associated with menstrual periods (PMS, headache, etc.).
Dosage and mode of application
Each Setlakin pack contains 84 active tablets (ethinyl estradiol + levonorgestrel) and 7 inert tablets (no hormones). Take 1 tablet per day for 91 days at the same time and in the order indicated on the package (blister).
To achieve the most reliable contraceptive effect, the drug should be taken in accordance with the recommendations and at intervals not exceeding 24 hours.
Tablets should be taken with a small amount of liquid.
Begin a new extended-cycle Setlakin pack without interruption. Follow the same order of admission.
Setlakin tablets can cause the following side effects:
- venous thrombosis;
- arterial thrombosis;
- cerebrovascular disorders;
- increased blood pressure;
- liver tumor;
- impaired liver function;
- impaired glucose tolerance or influence on peripheral insulin resistance;
- Crohn’s disease, ulcerative colitis, epilepsy, migraine, uterine myoma, cervical cancer, gallbladder stones, porphyria, herpes during pregnancy, Sydenham’s chorea, hemolytic-uremic syndrome, cholestatic jaundice, hearing loss associated with otosclerosis, jaundice and / or itching associated with cholestasis;
- acute pancreatitis;
- impaired vision;
- increase in body weight;
- pain in the back;
- nausea, pain in the abdomen;
- headache, migraine;
- painful menstrual-like bleeding; metrorrhagia, a sensitivity of mammary glands;
- fungal infections, nasopharyngitis.
Do not use Setlakin for birth control if you have any of the conditions listed below:
- hypersensitivity to ethinyl estradiol / levonorgestrel or any of the components of the drug;
- thromboses (venous and arterial) and thromboembolism (present or in the anamnesis);
- conditions preceding thrombosis (present or in the anamnesis);
- multiple or severe risk factors for venous or arterial thrombosis;
- hereditary or acquired predisposition to venous or arterial thrombosis;
- migraine with focal neurologic symptoms (present or in the anamnesis);
- uncontrolled arterial hypertension;
- diabetes mellitus with diabetic angiopathy;
- pancreatitis with severe hypertriglyceridemia (present or in the anamnesis);
- hepatic insufficiency and severe liver disease;
- liver tumors (present or in the anamnesis);
- severe dyslipoproteinemia;
- identified hormone-dependent malignant diseases (including genitals or mammary glands);
- bleeding from the vagina of unknown origin;
- simultaneous use of Setlakin with preparations of St. John’s wort perfumed;
- intolerance to galactose, insufficiency of lactase or glucose-galactose malabsorption (because the composition of the drug includes lactose);
- postmenopausal period;
- lactation period;
- age to 18 years.
- risk factors for thrombosis and thromboembolism: smoking, hereditary predisposition to thrombosis;
- dyslipoproteinemia, controlled arterial hypertension, migraine without focal neurological symptoms, uncomplicated heart valve disease;
- other diseases in which peripheral circulation disorders may occur: diabetes mellitus without diabetic angiopathy, hemolytic uremic syndrome, Crohn’s disease and ulcerative colitis, sickle cell anemia, phlebitis of superficial veins;
- liver disease of mild and moderate severity with normal liver function tests;
- diseases that first occurred or worsened during the previous pregnancy or against the background of the previous use of oral contraceptives ( jaundice,
- cholestasis, gallbladder disease, otosclerosis with hearing impairment, porphyria, herpes during pregnancy, Sydenham’s chorea);
- hereditary angioedema, chloasma, depression, epilepsy.
Before applying the medication, we recommend that you consult a doctor.
The contraceptive effect of Setlakin tablets can be reduced by antibiotics (ampicillin, rifampicin, chloramphenicol, neomycin, polymyxin B, sulfonamides, tetracyclines).
When taking oral hormonal contraceptives, you may need to adjust the dosage regimen for hypoglycemic drugs and indirect anticoagulants.
Some drugs may decrease the effectiveness of Setlakin:
- antiepileptic drugs (including primidone, phenytoin, barbiturates, carbamazepine, oxcarbazepine, topiramate, felbamate);
- antituberculosis drugs (including rifampicin, rifabutin);
- drugs for the treatment of HIV infection (including ritonavir, nevirapine);
- medicines based on St. John’s wort perfumed.
Pregnancy and breastfeeding
Setlakin is contraindicated in pregnancy and during breastfeeding.
If pregnancy is detected during the ruse of the contraceptive, the drug should be immediately discontinued. Extensive epidemiological studies have not revealed an increased risk of congenital malformations in children whose mothers received birth control pills prior to pregnancy or teratogenic effects with the occasional use of birth control pills in early pregnancy.
The contraceptive can reduce the amount of breast milk and change its composition, so its use is contraindicated until the termination of breastfeeding. A small number of active substances, ethinyl estradiol and levonorgestrel, can penetrate into breast milk and influence the child.
What if I miss a pill?
The reliability of the contraceptive may decrease if a woman has forgotten to take an active tablet (levonorgestrel + ethinyl estradiol), and especially if she forgot to take the first pill from the blister. If the delay in taking active tablets is less than 12 hours, the contraceptive protection is not reduced. A woman should take the pill as soon as possible. The next pill should be taken at the usual time. If the delay in taking active tablets is more than 12 hours, contraceptive protection can be reduced. Accordingly, if the delay in taking tablets exceeds 12 hours, a woman should follow the recommendations given below:
Week 1 (day 1-7):
The risk of pregnancy increases.
- If you missed 1 tablet, a woman should take it as soon as possible (even if you need to take 2 tablets at the same time). The next tablet is taken at the usual time;
- If you missed 2 tablets, a woman should take 2 tablets on the day when she remembered about the failure and 2 more tablets the next day. The further tablets are taken at the usual time. Additional non-hormonal barrier methods of contraception should be used for the next 7 days;
- If you missed 3 tablets, discard them. All subsequent tablets are taken at the usual time according to the directions given on the package. Within the next 7 days after missing the pills, a bleeding may occur. Anyway, an additional barrier method of contraception should be used for the next 7 days. If a woman had sexual intercourse within a week before missing a pill, she needs to exclude pregnancy.
Week 2-12 (day 8-84):
- 1 missed tablet should be taken as soon as possible, even if you have to take 2 tablets per day. The following tables are taken at the usual time. The use of additional methods of contraception is not required;
- If you missed 2 tablets, you should take 2 tablets on the day when you remembered about the failure, and 2 more tablets the next day. The further tablets are taken at the usual time. Additional barrier methods of contraception should be used for 7 days;
- If you missed 3 tablets, discard them. The subsequent tablets are taken at the usual time according to the directions given on the package. Within the next 7 days after missing the pills, a bleeding may occur. Additional barrier methods of contraception should be used for the next 7 days.
Week 13 (day 85-91):
Missed inert tablets should be discarded. All further tablets should be taken at the usual time. Additional methods of contraception are not required.
If a woman did not have withdrawal bleeding during the 13th week, the possibility of pregnancy should be excluded before starting a new 91-day course of Setlakin.
If you have serious gastrointestinal disturbances (vomiting or diarrhea in the period up to 3-4 hours after taking birth control pills), the absorption of the drug may be incomplete and additional contraceptive methods may be required. In these cases, you should follow the above recommendations for missed tablets.
If you have cardiovascular diseases, you should consult a doctor before taking this drug.
You should stop taking the medication and consult a doctor if you have symptoms of venous or arterial thrombosis: unilateral pain in the lower limb and / or swelling: sudden severe chest pain; sudden shortness of breath; sudden coughing attacks; unusual headache, sudden partial or complete loss of vision; slurred speech or aphasia; dizziness; fainting; weakness or very significant loss of sensitivity on one side or in one part of the body; motor disorders; “sharp” abdomen.
The risk of thrombosis and thromboembolism increases: with age, in smokers (the risk is especially high in smoking women over 35 years of age).
There are reports of a slight increase in the risk of developing cervical cancer with prolonged use of birth control pills. However, this connection has not been proven.
Women with hypertriglyceridemia have an increased risk of developing pancreatitis during treatment with oral contraceptives.
The effectiveness of the drug can be reduced by missing tablets, vomiting and diarrhea, or as a result of some drug interactions.
Before starting or resuming the use of Setlakin, it is necessary to undergo a thorough medical examination (including measurement of blood pressure, heart rate, determination of body mass index) and gynecological examinations, including breast examination and cytological examination of scrapings with the cervix (test for Pap test), exclude pregnancy. Usually, follow-up examinations should be undergone at least once every 6 months.
A woman should be informed that Setlakin does not protect against HIV infection (acquired immunodeficiency syndrome – AIDS) and other sexually transmitted diseases.
When taking birth control pills, irregular (acyclic) bleeding (spotting or breakthrough bleeding) can occur, especially during the first 3 months. Therefore, any irregular bleeding should be assessed only after an adaptation period which lasts approximately 3 cycles. If the bleeding is permanent or lasts too long, a woman should consult a doctor.
If a woman did not have a menstrual bleeding during the 13th week (when taking 7 inert tablets), the possibility of pregnancy should be excluded.
Conditions that require medical advice:
- any changes in the state of health, especially the emergence of conditions listed in the “With caution” section;
- local compaction in the mammary gland;
- simultaneous use of other medications (see the “Interactions” section);
- planned prolonged immobilization, hospitalization or a planned surgery (the drug should be canceled at least 4-6 weeks before the operation);
- severe bleeding from the vagina;
- a tablet was missed in the first week of taking the medication and you had sexual intercourse seven or fewer days before it;
- you have no menstrual bleeding which was expected (week 13);
- a suspicion of pregnancy (do not start taking birth control pills from the next package until you consult a doctor).
A woman should stop taking tablets and immediately consult a doctor if she has signs of thrombosis, myocardial infarction or stroke.
Setlakin does not affect the ability to drive vehicles and operate mechanisms.