Instructions Liberatti film-coated tablets 3.02 mg blister No. 28
Composition
active ingredients: ethinylestradiol, drospirenone;
1 film-coated tablet (pink) contains: ethinylestradiol 0.02 mg, drospirenone 3 mg;
excipients: lactose monohydrate, pregelatinized starch (corn), povidone K-30, croscarmellose sodium, polysorbate 80, magnesium stearate, coating: opadry® II pink (partially hydrogenated polyvinyl alcohol, titanium dioxide (E 171), macrogol 3350, talc (E 553b), yellow iron oxide (E 172), red iron oxide (E 172), black iron oxide (E 172)).
1 film-coated tablet, placebo (white) contains: anhydrous lactose, povidone K-30, magnesium stearate, coating: opadry®II white (partially hydrogenated polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc (E553b)).
Dosage form
Film-coated tablets.
Main physicochemical properties: round pink tablets, film-coated, without engraving; placebo: round white tablets, film-coated, without engraving.
Pharmacotherapeutic group
Hormonal contraceptives for systemic use. ATX code G03A A12.
Pharmacological properties
Pharmacodynamics.
The contraceptive effect of combined oral contraceptives (COCs) is based on the interaction of various factors, the most important of which are the suppression of ovulation and changes in cervical secretion.
In addition to preventing pregnancy, COCs have a number of other positive effects that are taken into account when choosing a birth control method. The menstrual cycle becomes regular, menstruation is less painful, and bleeding is reduced. This reduces the incidence of iron deficiency anemia.
Drospirenone, in addition to contraceptive properties, has additional properties, in particular antimineralocorticoid activity, which prevents weight gain and prevents symptoms associated with fluid retention. It counteracts sodium retention caused by estrogens, providing very good tolerability and positive effects in premenstrual syndrome (PMS). The use of the drug has been studied in connection with premenstrual dysphoric disorder (PMDD). PMDD is a severe form of PMS. In phase 3 of two placebo-controlled studies involving 500 women, the drug showed clinical efficacy in minimizing the symptoms of PMDD. In combination with ethinylestradiol, drospirenone has a positive effect on the lipid profile, increasing the content of high-density lipoproteins. Drospirenone has an antiandrogenic effect, which is manifested by a positive effect on the skin, reducing the severity of acne and sebum production. Drospirenone also does not counteract the ethinylestradiol-induced increase in sex steroid binding globulin (SSGB), which is useful for binding and inactivating endogenous androgens.
In two multicenter, double-blind, randomized, placebo-controlled studies of the efficacy and safety of the drug in the treatment of moderate acne vulgaris, the drug demonstrated a clinically and statistically significant effect on both the primary efficacy endpoints (number of inflammatory and non-inflammatory elements, total number of lesions (elements), number and percentage of women with “clear” and “almost clear” skin, as assessed by the ISGA scale, and most secondary endpoints.
Drospirenone has no androgenic, estrogenic, glucocorticoid or antiglucocorticoid activity, which in combination with antimineralocorticoid and antiandrogenic properties indicates that the pharmacological and biochemical profile of drospirenone is similar to the natural hormone progesterone. There is evidence of a reduced risk of endometrial and ovarian cancer with COC use. It has been shown that with the use of high-dose COCs
(50 mcg ethinylestradiol) reduces the risk of ovarian cysts, pelvic inflammatory disease, benign breast disease and ectopic pregnancy. Whether this applies to low-dose COCs has not been definitively established.
No special risk to humans has been identified in standard studies of repeated dose toxicity, genotoxicity, carcinogenicity and toxicity to reproduction. However, it should be borne in mind that sex steroids may promote the growth of certain hormone-dependent tissues and pre-existing tumours.
Pharmacokinetics.
Drospirenone
Absorption
Orally administered drospirenone is rapidly and completely absorbed. The maximum serum concentration of 35 ng/ml is reached approximately 1-2 hours after a single oral dose. Bioavailability is 76-85%. Simultaneous food intake does not affect bioavailability.
Distribution
After oral administration, the level of drospirenone in the blood decreases in two phases with a half-life of 1.6 ± 0.7 hours and 27.0 ± 7.5 hours, respectively.
Drospirenone binds to serum albumin, but not to GHB or corticoid-binding globulin. Only 3-5% of its total amount in serum is present in the free state. The increase in GHB caused by ethinylestradiol does not affect the binding of drospirenone to serum proteins. The mean volume of distribution of drospirenone is 3.7 ± 1.2 l/kg.
Drospirenone is completely metabolized after oral administration. The main metabolites in plasma are the acid forms of drospirenone, formed by opening the lactone ring, and 4,5-dihydro-drospirenone-3-sulfate, these metabolites are formed without the involvement of the P450 system.
Drospirenone is metabolized to a minor extent by cytochrome P450 3A4 and has demonstrated the ability to inhibit this enzyme, as well as cytochrome P450 1A1, cytochrome P450 2C9 and cytochrome P450 2C19 in vitro.
Excretion from the body
The metabolic clearance rate of drospirenone from serum is approximately 1.5 ± 0.2 ml/min/kg. Drospirenone is excreted unchanged only in very small amounts. The metabolites are excreted in urine and feces in a ratio of 1.2 to 1.4. The half-life of the metabolites in urine and feces is approximately 40 hours.
State of equilibrium
During the course of the treatment cycle, the maximum steady-state serum concentration of drospirenone, approximately 60 ng/ml, is reached between the 7th and 14th day of administration. Blood levels of drospirenone increased 2- to 3-fold as a result of the ratio of the terminal half-life to the dosing interval. A further increase in drospirenone levels after treatment was observed between cycles 1 and 6, but was not observed thereafter.
Certain groups of patients
Women with impaired kidney function
The steady-state serum concentration of drospirenone in women with mild renal impairment (creatinine clearance 50-80 ml/min) was comparable to that in women with normal renal function (creatinine clearance >80 ml/min). The serum level of drospirenone was on average 37% higher in women with moderate renal impairment (creatinine clearance 30-50 ml/min) compared to that in women with normal renal function. The use of drospirenone was well tolerated in all patient groups. It was shown that drospirenone administration has no clinically significant effect on serum potassium concentration.
Women with liver dysfunction
In women with moderate hepatic impairment (Child-Pugh class B), the time-dependent mean serum drospirenone concentration was comparable to that in women with normal hepatic function during the absorption/distribution phases with similar Cmax values. The decrease in serum drospirenone concentration during the terminal distribution phase was approximately 1.8 times greater in volunteers with moderate hepatic impairment than in volunteers with normal hepatic function. In volunteers with moderate hepatic impairment, an approximately 50% decrease in apparent oral clearance was observed compared to that in women with normal hepatic function. This decrease in clearance did not result in any difference in blood potassium concentrations between the two groups of volunteers. Even in the presence of diabetes and concomitant treatment with spironolactone (two factors predisposing to hyperkalemia), no increase in serum potassium concentration above the upper limit of the normal range was observed. It can be concluded that drospirenone is well tolerated in patients with mild to moderate hepatic insufficiency (Child-Pugh class B).
Ethnic groups
The effect of ethnic factors on the pharmacokinetics of drospirenone and ethinyl estradiol was studied after single and repeated daily dosing in young healthy Caucasian and Asian women. The results showed that ethnic differences had no clinically significant effect on the pharmacokinetics of drospirenone and ethinyl estradiol.
Ethinylestradiol
Absorption
When administered orally, ethinylestradiol is rapidly and completely absorbed. Maximum serum concentrations of 88-100 pg/ml are reached within 1-2 hours after a single oral dose. Absolute bioavailability due to presystemic conjugation and first-pass metabolism is approximately 60%. Concomitant food intake reduces the bioavailability of ethinylestradiol in approximately 25% of subjects.
Distribution
Serum ethinylestradiol levels decline in a biphasic manner, with a terminal half-life of approximately 24 hours. Ethinylestradiol binds strongly but nonspecifically to serum albumin (approximately 98.5%) and induces an increase in serum GSH concentrations. The apparent volume of distribution is approximately 5 l/kg.
Metabolism
Ethinylestradiol is metabolized mainly by hydroxylation of the aromatic ring to form a wide range of hydroxylated and methylated metabolites, which are present in the free state and as conjugates with glucuronides and sulfates. The metabolic clearance of ethinylestradiol is approximately 5 ml/min/kg.
Excretion from the body
Ethinylestradiol is practically not excreted unchanged. Metabolites of ethinylestradiol are excreted in urine and bile in a ratio of 4:6. The half-life of metabolites is almost 1 day.
State of equilibrium
Steady state is reached in the second half of the cycle of use, when the concentration of ethinylestradiol in serum increases by 1.4 - 2.1 times.
Indication
Oral contraception (especially suitable for women with hormone-dependent fluid retention and associated symptoms); treatment of mild acne vulgaris in women who have chosen oral contraception to prevent pregnancy; treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraception to prevent pregnancy.
Contraindication
Liberatti® should not be used in the presence of at least one of the following conditions or diseases. If any of these conditions or diseases appear for the first time during use of the drug, its use should be discontinued immediately.
· Venous or arterial thrombotic/thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction) or cerebrovascular disorder, current or history.
· Current or history of prodromal symptoms of thrombosis (e.g. transient ischemic attack, angina pectoris).
· The presence of severe or multiple risk factors for the development of venous or arterial thrombosis.
· Migraine with focal neurological symptoms in history.
· Diabetes mellitus with vascular damage.
Severe liver disease until liver function tests have returned to normal.
Severe renal failure or acute renal failure.
· Current or history of liver tumors (benign or malignant).
Known or suspected malignant tumors (e.g., genital or breast) that are sex hormone-dependent.
· Vaginal bleeding of unknown etiology.
Known or suspected pregnancy.
· Hypersensitivity to the active substances or to any of the components of the drug.
Interaction with other medicinal products and other types of interactions
Interaction of oral contraceptives and other drugs (enzyme inducers, some antibiotics) may lead to breakthrough bleeding and/or loss of contraceptive efficacy. When treated with any of these drugs, a barrier method should be temporarily used in addition to COC use or another method of contraception should be chosen. When treated with drugs that induce microsomal enzymes, a barrier method should be used throughout the entire period of treatment with the corresponding drug and for 28 days after its discontinuation.
When treating with an antibiotic (except rifampicin and griseofulvin), the barrier method should be used for 7 days after its cancellation. If the barrier method is still used, and the tablets in the current package have already ended, you should start taking the tablets from the next package without a break in taking the drug.
Interactions may occur with drugs that induce microsomal enzymes, increasing the clearance of sex hormones (e.g. phenytoin, barbiturates, primidone, carbamazepine, rifampicin and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and drugs containing St. John's wort).
HIV protease inhibitors (e.g. ritonavir) and non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and their combinations also have the potential to affect hepatic metabolism.
The results of some clinical studies suggest that enterohepatic circulation of estrogens may be reduced when taking certain antibiotics that can reduce the concentration of ethinylestradiol (for example, penicillin and tetracycline antibiotics).
The main metabolites of drospirenone in blood plasma are formed without the involvement of the cytochrome P450 system. Inhibitors of this enzyme system do not affect the metabolism of drospirenone.
Liberati® may affect the metabolism of other drugs. Accordingly, plasma and tissue concentrations may increase (e.g. cyclosporine) or decrease (e.g. lamotrigine).
Based on in vitro inhibition studies and in vivo interaction studies in female volunteers using omeprazole, simvastatin and midazolam as marker substrates, it was found that the interaction of drospirenone at a dose of 3 mg with the metabolism of other drugs is unlikely.
Other forms of interaction
When Liberatti® is used simultaneously with drugs that can increase serum potassium levels, it is theoretically possible to increase it.
Laboratory tests
The use of contraceptive steroids may affect the results of certain laboratory tests. Drospirenone causes an increase in plasma renin and aldosterone activity, which is induced by its moderate antimineralocorticoid activity.
Application features
Circulatory disorders
The risk of venous thromboembolism is highest during the first year of COC use. This increased risk exists after starting COC use or resuming use (after a 4-week or longer tablet-free interval) of the same or a different oral contraceptive. Data from a large prospective study suggest that this increased risk persists mainly during the first 3 months.
The overall risk of venous thromboembolism (VTE) in women using low-dose oral contraceptives (< 50 μg ethinylestradiol) is 2-3 times higher than in never users, and remains lower than the risk associated with pregnancy and childbirth. VTE can be life-threatening or fatal (in 1-2% of VTE cases).
Venous thromboembolism, manifested as venous thrombosis and/or pulmonary embolism, can occur with the use of any COC.
Thrombosis in other blood vessels, such as arteries and veins of the liver, kidneys, mesenteric vessels, brain or retina, has been reported extremely rarely in women using COCs.
Symptoms of deep vein thrombosis may include: unilateral swelling of the leg or an area along a vein in the leg; pain or increased sensitivity in the leg that may only be felt when standing or walking; a feeling of heat in the affected leg; redness or discoloration of the skin on the leg.
Symptoms of pulmonary embolism may include: sudden unexplained shortness of breath or rapid breathing; sudden cough, possibly with blood; sudden chest pain that may worsen with deep breathing; anxiety; dizziness; fast or irregular heartbeat. Some of these symptoms (e.g., shortness of breath, cough) are nonspecific or may be misinterpreted as more common or less severe conditions (e.g., respiratory tract infections).
Arterial thromboembolic events may include cerebrovascular accident, vascular occlusion, or myocardial infarction. Symptoms of cerebrovascular accident may include: sudden numbness of the face, arm, or leg, especially on one side; sudden confusion, slurred speech, or understanding; sudden loss of vision in one or both eyes; sudden trouble walking, dizziness, loss of balance, or coordination; sudden, severe, or prolonged headache with no known cause; loss of consciousness with or without seizures. Other symptoms of vascular occlusion may include: sudden pain, swelling, or mild bluish discoloration of the extremities; and a "sharp" abdomen.
Symptoms of a myocardial infarction may include: pain, discomfort, squeezing, heaviness, a feeling of squeezing or heaviness in the chest, arm, or below the breastbone; discomfort that radiates to the back, jaw, throat, arm, or stomach; a feeling of fullness, indigestion, or heartburn; excessive sweating, nausea, vomiting, or dizziness; extreme weakness, anxiety, or shortness of breath; and a fast or irregular heartbeat.
Arterial thromboembolic events can be life-threatening or fatal.
Factors that increase the risk of venous or arterial thrombotic/thromboembolic events or cerebrovascular accident:
- age;
- obesity (body mass index more than 30 kg/m2);
- a complicated family history (e.g. cases of venous or arterial thromboembolism in siblings or parents at a relatively young age). If there is or is suspected of a hereditary predisposition, it is recommended to seek medical advice before starting any COC;
- prolonged immobilization, radical surgery, any surgery on the lower extremities, significant trauma. In these cases, it is recommended to stop using COCs (in the case of elective surgery at least 4 weeks before it) and to resume taking them no earlier than 2 weeks after full recovery of mobility;
- smoking (with heavy smoking, the risk increases with age). When using COCs, it is worth quitting smoking, especially if you are over 35 years old);
- dyslipoproteinemia;
- arterial hypertension;
- migraine;
- heart valve defects;
- atrial fibrillation.
There is no consensus on the possible role of varicose veins and superficial thrombophlebitis in the development of venous thromboembolism.
It is necessary to take into account the increased risk of thromboembolism in the postpartum period.
Other diseases that may be associated with circulatory disorders include: diabetes mellitus; systemic lupus erythematosus; hemolytic uremic syndrome; chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis), and sickle cell anemia.
An increase in the frequency of migraine or its worsening during COC use (which may be a harbinger of cerebrovascular accident) may require urgent discontinuation of COC use.
When analyzing the risk/benefit ratio, it is recommended to take into account the fact that adequate treatment of the conditions mentioned above can reduce the associated risk of thrombosis, as well as the fact that the risk of thrombosis associated with pregnancy is higher than with the use of low-dose COCs (< 0.05 mg ethinylestradiol).
Tumors
The most important risk factor for cervical cancer is the persistence of human papillomavirus. The results of some epidemiological studies indicate an additional increase in the risk of cervical cancer with long-term use of COCs, but since it is not yet clear to what extent the results of the studies take into account concomitant risk factors, such as cervical screening and sexual behavior, including the use of barrier methods of contraception.
A meta-analysis of 54 epidemiological studies has shown a slightly increased relative risk (RR = 1.24) of developing breast cancer in women who use COCs. This increased risk gradually disappears within 10 years after stopping COC use. Since breast cancer is rare in women under 40 years of age, the increase in the number of cases diagnosed with breast cancer in women who are currently or have recently used COCs is small in relation to the overall risk of breast cancer. The results of these studies do not provide evidence of a causal relationship. The increased risk may be due to earlier diagnosis of breast cancer in women who use COCs, the biological effects of COCs, or a combination of both. There is a tendency for breast cancer detected in women who have ever used COCs to be clinically less severe than in those who have never used COCs.
In isolated cases, benign and even more rarely malignant liver tumors have been observed in women using COCs, which in some cases led to life-threatening intra-abdominal bleeding. In the event of complaints of severe pain in the epigastric region, liver enlargement or signs of intra-abdominal bleeding, the possibility of a liver tumor should be considered in the differential diagnosis when using COCs.
Malignant neoplasms can lead to fatal consequences.
Other states
Patients with renal insufficiency may have a limited ability to excrete potassium. In a clinical study, it was found that drospirenone did not affect serum potassium concentrations in patients with mild to moderate renal insufficiency. The risk of hyperkalemia is theoretically possible only in patients with renal insufficiency whose serum potassium concentration before treatment was in the upper limits of the control range and who are additionally taking potassium-sparing drugs.
Women with hypertriglyceridemia or a family history of this disorder are at risk of developing pancreatitis when using COCs.
Although a slight increase in blood pressure has been reported in many women taking COCs, a clinically significant increase in blood pressure is rare. However, if persistent clinically significant hypertension develops during COC use, it is advisable to discontinue COC use and treat the hypertension. If appropriate, COC use may be resumed after normotensive status has been achieved with antihypertensive therapy.
The following conditions have been reported to occur or worsen during pregnancy and COC use, but the relationship between the two conditions and COC use is not conclusive: jaundice and/or pruritus associated with cholestasis, gallstone formation, porphyria, systemic lupus erythematosus, haemolytic uraemic syndrome, Sydenham's chorea, herpes gestationis, hearing loss associated with otosclerosis.
In acute or chronic liver dysfunction, it may be necessary to discontinue COC use until liver function tests have returned to normal. In the event of recurrence of cholestatic jaundice, which first occurred during pregnancy or previous use of sex hormones, COC use should be discontinued.
Although COCs may affect peripheral insulin resistance and glucose tolerance, there is no evidence to suggest that diabetic women taking low-dose COCs (<0.05 mg ethinylestradiol) should be monitored closely during COC use.
Crohn's disease and ulcerative colitis may be associated with COC use.
Chloasma may occasionally occur, especially in women with a history of chloasma during pregnancy. Women prone to chloasma should avoid exposure to direct sunlight or ultraviolet radiation while using COCs.
Each tablet with active ingredients contains 44 mg of lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should take this amount of lactose into account.
Before starting or reinstituting Liberatti®, a complete medical history and physical examination are recommended. Periodic examinations should be performed while using COCs. Such periodic examinations are important because conditions mentioned in the Contraindications section (e.g. transient ischemic attack, etc.) or risk factors (e.g. family history of venous or arterial thrombosis) may appear for the first time during COC use.
The frequency and nature of these examinations should be based on existing standards of medical practice, taking into account the individual characteristics of each woman, but generally include, at a minimum, blood pressure measurement, examination of the mammary glands, abdominal and pelvic organs, and cytological examination of the cervix.
Liberatti®, like other combined oral contraceptives, does not protect against infection.
HIV infection (AIDS) or any other sexually transmitted disease.
Decreased efficiency
The effectiveness of combined oral contraceptives may be reduced in case of missed pills, gastrointestinal disorders, or the use of other medications.
Cycle control
When taking oral contraceptives, you may experience intermenstrual bleeding (spotting or breakthrough bleeding), especially during the first few months. Irregular vaginal bleeding usually stops as the body adapts to the drug (usually after 3 cycles of taking the pill).
If irregular bleeding persists after a period of adaptation or occurs after a period of regular bleeding, non-hormonal causes of bleeding should be considered and appropriate diagnostic measures should be taken, including examination to exclude tumors and pregnancy. Diagnostic measures may include curettage.
Some women may not have a withdrawal bleed during the tablet-free interval. If the COC has been taken according to the instructions, pregnancy is unlikely. However, if the contraceptive has been taken irregularly or if there has been no withdrawal bleed for two cycles before continuing COC use, pregnancy should be ruled out.
Use during pregnancy or breastfeeding.
Pregnancy.
The drug is contraindicated for use during pregnancy. If pregnancy occurs while taking Liberatti®, its use should be discontinued immediately. However, epidemiological studies do not indicate an increased risk of congenital malformations in children whose mothers took COCs before pregnancy, nor does they indicate a teratogenic effect in the event of inadvertent COC use during pregnancy.
Animal studies have shown undesirable effects during pregnancy and lactation (see section 5.1). Based on these animal studies, undesirable effects due to the hormonal action of the active substances cannot be excluded. However, the general experience of the use of COCs during pregnancy does not indicate any undesirable effects in humans.
The available data on the use of the drug during pregnancy are too limited to draw conclusions about the negative effects of the drug Liberatti on the course of pregnancy, the health of the fetus and the newborn. There are currently no relevant epidemiological data.
When resuming the use of LiberattiÒ
The increased risk of VTE in the postpartum period should be taken into account (see sections “Method of administration and dosage”, “Special precautions for use”).
Breast-feeding.
COCs may affect breastfeeding, as they may reduce the amount of breast milk and change its composition. Therefore, COCs are not recommended during breastfeeding. Small amounts of contraceptive steroids and/or their metabolites may pass into breast milk during COC use. These amounts may affect the child.
The ability to influence the reaction speed when driving or working with other mechanisms
No studies have been conducted on the effect of Liberatti® on the reaction speed when driving or operating other mechanisms. No effect on the ability to drive or operate machinery has been observed in women using COCs.
Method of administration and doses
When combined oral contraceptives (COCs) are used correctly, the risk of pregnancy is approximately 1% per year. If you miss a pill or use it incorrectly, the risk of pregnancy may increase.
The tablets should be taken daily in the order indicated on the blister, at about the same time, with a small amount of liquid. The drug is taken 1 tablet per day for 28 consecutive days. Taking the tablets from each subsequent package should be started the day after the end of the previous package.
The packaging includes a blister holder in which you can place the blister when you need to take it with you, and a calendar scale.
The blister contains 24 tablets with active ingredients (pink tablets) and 4 placebo tablets (white tablets) that do not contain active ingredients.
If hormonal contraceptives were not used in the previous period (last month), taking the tablets should be started on the first day of the natural cycle (i.e. on the first day of menstrual bleeding). You can also start taking them on the 2nd-5th day, but in this case you must use an additional method of contraception (for example, a barrier method) during the first 7 days of taking the drug.
Switching from another combined oral contraceptive (COC), vaginal ring or transdermal patch:
It is advisable to start taking Liberati® tablets the day after taking the last hormone-containing tablet of your previous COC, but no later than the day after the tablet-free interval or after taking the placebo tablets of your previous COC. If you are using a contraceptive vaginal ring or transdermal patch, you should start taking Liberati® on the day of removal, but no later than the day when the next dose of these products would have been due.
Switching from a progestogen-only method (mini-pill, injection, implant or progestogen-only intrauterine system):
You can start taking Liberati® any day after stopping the mini-pill (in the case of an implant or intrauterine system - on the day of their removal, in the case of an injection - instead of the next injection). However, in all cases it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the drug.
After an abortion in the first trimester of pregnancy:
You can start taking Liberatti® immediately. In this case, there is no need to use additional contraceptive measures.
After childbirth or abortion in the second trimester:
in case of breastfeeding, see the section "Use during pregnancy or breastfeeding". It is recommended to start taking Liberatti® on the 21st-28th day after childbirth or abortion in the second trimester of pregnancy. If you start taking the tablets later, it is recommended to additionally use a barrier method of contraception during the first 7 days of taking the tablets. However, if sexual intercourse has already taken place, then before starting the drug, you should exclude a possible pregnancy or wait for the first menstruation.
What to do if you miss a pill
The missed placebo tablets can be ignored. However, they should be removed from the pack to avoid unintentionally prolonging the placebo phase. The following instructions only apply to missed pink tablets containing active substances.
If the delay in taking the pink tablet does not exceed 24 hours, the contraceptive effect of the drug is not reduced. The missed tablet should be taken as soon as it is found out. The next tablet from this package should be taken at the usual time.
If you are more than 24 hours late in taking the pink pill, contraceptive protection may be reduced. In this case, you should follow two basic rules:
1. The break in taking pills should never exceed 4 days.
2. Adequate suppression of the hypothalamic-pituitary-ovarian system is achieved by continuous tablet intake for 7 days.
Accordingly, in everyday life you should follow the following recommendations:
· Day 1-7
The last missed tablet should be taken as soon as possible, even if this means taking two tablets at the same time. After that, continue taking the tablets at the usual time. In addition, a barrier method of contraception, such as a condom, should be used for the next 7 days. If sexual intercourse has taken place in the previous 7 days, the possibility of pregnancy should be considered. The more tablets are missed and the closer the placebo tablet period is, the greater the risk of pregnancy.
· Day 8-14
You should take the last missed tablet as soon as possible, even if this means taking two tablets at the same time. Then continue
